{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "NO INFORMATION", "report_to_fda": "I", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "N", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "MW5066629", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20161207", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20160912", "reprocessed_and_reused_flag": "I", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20161212", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "804451", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20161207", "brand_name": "DA VINCI SURGICAL SYSTEM (ROBOT)", "generic_name": "DA VINCI SURGICAL SYSTEM (ROBOT)", "manufacturer_d_name": "INTUITIVE SURGICAL INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No answer provided", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Fail-Safe Design Failure", "Device Operates Differently Than Expected" ], "reporter_state_code": "MA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250815", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "0", "date_received": "20161207", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " L", " R", " S" ], "patient_age": "24 YR", "patient_sex": "", "patient_weight": "76", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Pain", "Pneumonia", "Peritonitis", "Bowel Perforation", "Abscess", "Pain", "Pneumonia", "Peritonitis", "Bowel Perforation" ] }, { "patient_sequence_number": "1", "date_received": "20161207", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " L", " R", " S" ], "patient_age": "24 YR", "patient_sex": "", "patient_weight": "76", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pain", "Pneumonia", "Peritonitis", "Bowel Perforation", "Pain", "Pneumonia", "Peritonitis", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20161129", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6166274", "removal_correction_number": "", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Voluntary report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "241267457", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 03/01/2017 FOR MW5066629: I SUBMITTED A MEDICAL DEVICE REPORT AFTER MY SON WAS INJURED FOLLOWING SURGERY WITH A DA VINCI ROBOTIC SYSTEM. (MW5066629) AFTER I SUBMITTED MY REPORT TO YOUR AGENCY, I RECEIVED A CALL FROM SOMEONE IN THE REGULATORY COMPLAINTS DEPARTMENT AT INTUITIVE SURGICAL (MAKERS OF THE DA VINCI ROBOTIC SYSTEM). HE SAID HE HAD RECEIVED A COPY OF MY SON'S INJURY REPORT FROM THE FDA AND HE WANTED TO KNOW THE NAME OF THE SURGEON AND THE HOSPITAL WHERE THE INJURY HAPPENED. HE HAD THE DATE OF THE SURGERY, KNEW FROM MY AREA CODE THAT I WAS FROM THE (B)(6) AREA AND SAID HE DID HAVE ONE REPORT OF AN INJURY BEING REPORTED IN (B)(6) ON OR AROUND THAT DATE. ((B)(6) 2016 WAS THE DATE OF THE INITIAL SURGERY, (B)(6) 2016 WAS THE DATE OF THE EMERGENCY SURGERY AFTER THE INJURY WAS DISCOVERED). I RESPONDED, \"OH GOOD, SO THE SURGEON OR THE HOSPITAL DID REPORT THE INJURY PROCEEDING THE DA VINCI SURGERY TO YOUR COMPANY.\" THE MAN IN THE REGULATORY DEPARTMENT THEN SAID, \"WELL NOT EXACTLY, THE SURGEON REPORTED THE INJURY TO OUR DA VINCI SALES PERSON, AND I FILED MY REPORT TO THE FDA BASED UPON WHAT OUR SALES PERSON REPORTED TO ME.\" (I FOUND IT STRANGE THAT THE REPORT OF A POTENTIALLY FATAL INJURY WAS REPORTED TO A SALES PERSON FOR THE VERY MACHINE THAT WAS AT THE ROOT OF THAT INJURY, INSTEAD OF TO THE COMPANY OR TO THE FDA DIRECTLY.) THE REPRESENTATIVE FROM INTUITIVE THEN SAID, \"OUR SALES PERSON REPORTED THAT HE RECEIVED A CALL FROM THE SURGEON, WHO SAID THAT 'AN INJURY OCCURRED BUT THE DA VINCI SURGERY WENT WELL WITH NO COMPLICATIONS, NO MALFUNCTIONS OF THE DA VINCI SYSTEM OR ANY OF THE ACCESSORIES AND SO THE ROOT CAUSE OF THE SUBSEQUENT INJURY IS UNKNOWN.' THAT WAS THE SURGEON'S PERSPECTIVE AND SO I WENT AHEAD AND FILED THAT REPORT TO THE FDA, MY REPORT IS ON FILE WITH THE FDA. IF YOU GO TO THE FDA MAUDE DATABASE AND ENTER REPORT # 2955842-2016-00747, YOU SHOULD SEE MY REPORT; IT IS PUBLIC.\" HE ASKED ME SOME OTHER QUESTIONS. I MENTIONED THAT ALONG WITH DR. (B)(6), THERE IS ALSO DR. (B)(6) AND A DR. (B)(6)(RESIDENT,) LISTED ON (B)(6)'S MEDICAL RECORDS AND I WENT ON TO SAY THAT WHEN (B)(6) WAS DISCHARGED, THE PERSON DISCHARGING HIM TOLD (B)(6) AND ME THAT DR. (B)(6) DIDN'T DO THE SURGERY. HE TOOK THESE NAMES. HE APOLOGIZED FOR WHAT (B)(6) HAD GONE THROUGH AND I SAID THAT (B)(6) HAD EXPERIENCED ALMOST EVERY COMPLICATION FROM ROBOTIC SURGERY, OTHER THAN DEATH, POSSIBLE AND I FOUND IT REMARKABLE THAT DR. (B)(6) WOULD SAY EVERYTHING WENT WELL. THE INTUITIVE REPRESENTATIVE THEN ASKED ME HOW THE INJURY WAS EXPLAINED TO ME... I TOLD HIM THAT DR. (B)(6) EXPLAINED (WHEN HE MET ME AT (B)(6) WHILE (B)(6) WAS IN EMERGENCY SURGERY FOR A PERFORATED SMALL INTESTINE, ABSCESS, AND PERITONITIS, WHICH INCLUDED A SMALL INTESTINE RESECTION, ABDOMINAL WASHOUT, ETC., AND RESULTED IN TOO MANY SUBSEQUENT COMPLICATIONS TO EVEN GO INTO.)... DR. (B)(6) EXPLAINED THE INJURY TO ME THAT, \"THE INSTRUMENT WE LIFTED THE GALLBLADDER OFF OF THE LIVER BED WITH IS VERY HOT, IT CAUTERIZES AND THAT MUST HAVE WHAT PERFORATED (B)(6)'S INTESTINE, BUT I AM SURPRISED BECAUSE I DID NOT SEE ANYTHING AND THERE WAS A CAMERA IN THERE.\" THE REPRESENTATIVE THEN SAID, \"WELL I WONDER IF THE SURGEON SWITCHED FROM A ROBOTIC SURGERY TO A MANUAL (OR, TRADITIONAL?) SURGERY AND THAT WAS WHY HE WAS USING THE INSTRUMENT.\" (B)(6)'S SURGERY WAS NOT SWITCHED MID-SURGERY. IT WAS A ROBOTIC SURGERY WHERE TWO AND A HALF DAYS LATER HIS CONDITION DECLINED SO BADLY THAT HE ENDED UP BACK IN THE ER WHERE THE PERITONITIS WAS DISCOVERED AND EMERGENCY SURGERY WAS NECESSARY DUE TO HIS INTESTINES HAVING BEEN PERFORATED DURING THE ROBOTIC SURGERY. I AM ENCLOSING TWO PAGES FROM (B)(6)'S MEDICAL RECORDS, WHICH STATE, \"(B)(6) YEARS OLD WHO HAD A ROBOTIC CHOLECYSTECTOMY FOR CHRONIC CHOLECYSTITIS. IN EARLY (B)(6) THAT WAS COMPLICATED BY AN ENTEROTOMY THAT WAS INITIALLY NOT RECOGNIZED AND THEN REQUIRED AN URGENT LAPAROTOMY 2 DAYS LATER.\" AND ANOTHER PAGE FROM HIS RECORDS STATING, \"2 DAYS AFTER A LAPAROSCOPIC ROBOTIC CHOLECYSTECTOMY... AN ENTEROTOMY THROUGH AN EXACT SITE OF PERFORATION IS NOT IDENTIFIED. WILL PROCEED WITH EXPLORATORY LAPAROTOMY TO IDENTIFY AND TREAT THE SOURCE OF PERFORATION.\" (B)(6)'S INJURY WAS EXPLAINED TO ME THROUGHOUT (B)(6)'S EXTENSIVE HOSPITALIZATION AS HAVING BEEN A RESULT OF HIS ROBOTIC SURGERY, AND FOR THE SURGEON WHO ORDERED HIS INITIAL SURGERY TO TELL ME \"THE PERFORATION HAPPENED FROM THE 'HOT INSTRUMENT,' WHICH WE DID NOT SEE\" - AND THEN SUBSEQUENTLY TELL THE SALESPERSON FOR THE DA VINCI SYSTEM THAT \"THE DA VINCI SURGERY WENT WELL AND THE ROOT CAUSE OF THE INJURY IS UNKNOWN\" IS PREPOSTEROUS. EVERY DOCTOR (B)(6) HAS SEEN IN THE FIVE AND A HALF MONTHS SINCE HIS INJURY, AS HE TRIES TO NAVIGATE HIS RECOVERY, HAD SAID, \"HAD HE BEEN ANY OLDER OR ANY LESS HEALTHY, HE WOULD NOT HAVE LIVED THROUGH THIS INJURY.\" THE ELECTRICAL CURRENT THAT ARCS FROM THE ROBOT IS KNOWN FOR PERFORATING NEARBY ORGANS, AND THE FACT THAT THIS IS NOT SEEN AT THE TIME OF THE SURGERY PART OF THE SYSTEM'S PROBLEM AND THAT IS WHY PATIENTS ARE RELEASED AND THEIR INJURIES ARE NOT DISCOVERED UNTIL DAYS LATER, WHEN THEY BECOME VERY SICK. IT WAS BAD ENOUGH THAT THIS HAPPENED TO (B)(6), HE WILL LIVE WITH THE REPERCUSSIONS FROM THIS FOR THE REST OF HIS LIFE, BUT FOR THE SURGEON TO GO TO A DA VINCI SALES PERSON AND SAY THAT \"THE SYSTEM WORKED WELL AND THE ROOT CAUSE OF THE INJURY IS UNKNOWN\" IS UNTHINKABLE. THAT REPORT IS DEMONSTRABLY FALSE. (I SHOULD ADD, THE SURGEON HAS NOT SEEN (B)(6) ONCE SINCE HIS EMERGENCY SURGERY, ALTHOUGH HE DID CALL ME TWO WEEKS AGO, TO ASK HOW (B)(6) WAS DOING. I SAID THAT HIS PRIMARY CARE DOCTOR HAS TAKEN OVER SINCE NEITHER HE NOR (B)(6) WAS REMOTELY HELPFUL IN FOLLOWING UP ON (B)(6) OR DEALING WITH THE COMPLICATIONS HE HAS EXPERIENCED AND THE SURGEON SAID, \"I REALLY DON'T KNOW WHY HIS RECOVERY IS SO SLOW, IT WASN'T THAT BIG A DEAL... HE IS A YOUNG STRONG (B)(6) YEAR OLD, IT SHOULDN'T HAVE BEEN THAT BIG A DEAL.\" THIS IS HARD TO FATHOM. THE DEVICE WILL CONTINUE TO INJURE PATIENTS AND SURGEONS AND HOSPITALS ARE MORE CONCERNED WITH INCREASING SURGERIES WITH THE SYSTEM, AND INTUITIVE'S SALES PEOPLE ARE MORE CONCERNED WITH INCREASED SALES OF THE ROBOTIC SYSTEMS, THAN THEY ARE WITH PATIENT'S SAFETY OR LIVES AT STAKE. PLEASE UPDATE (B)(6)'S REPORT." }, { "mdr_text_key": "241268709", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2016 MY SON, (B)(6) HAD HIS GALL BLADDER REMOVED AT (B)(6) HOSPITAL BY ROBOTIC SURGERY. TWO DAYS LATER I TOOK HIM TO THE ER WHERE IT WAS DISCOVERED THAT HIS SMALL INTESTINES HAD BEEN PUNCTURED DURING SURGERY. ULTIMATELY, HE HAD TO HAVE SMALL BOWEL RESECTION, HE HAD PERITONITIS, ETC. LIST ALL CURRENT PRESCRIPTION MEDICATIONS AND MEDICAL DEVICES BEING USE: NONE, JUST FINISHED A 2-PACK, AS HE WAS JUST DIAGNOSED WITH PNEUMONIA. LIST ALL OVER-THE-COUNTER MEDICATIONS: NONE (ADVIL FOR PAIN) OCCASIONALLY, WHEN HE CANNOT STAND IT." }, { "mdr_text_key": "62225213", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2016 MY SON, (B)(6) HAD HIS GALL BLADDER REMOVED AT (B)(6) HOSPITAL BY ROBOTIC SURGERY. TWO DAYS LATER I TOOK HIM TO THE ER WHERE IT WAS DISCOVERED THAT HIS SMALL INTESTINES HAD BEEN PUNCTURED DURING SURGERY. ULTIMATELY, HE HAD TO HAVE SMALL BOWEL RESECTION, HE HAD PERITONITIS, ETC. LIST ALL CURRENT PRESCRIPTION MEDICATIONS AND MEDICAL DEVICES BEING USE: NONE, JUST FINISHED A 2-PACK, AS HE WAS JUST DIAGNOSED WITH PNEUMONIA. LIST ALL OVER-THE-COUNTER MEDICATIONS: NONE (ADVIL FOR PAIN) OCCASIONALLY, WHEN HE CANNOT STAND IT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "03/01/2017" } ] }