{ "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": "HOSPITAL", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2013-04947", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20100104", "reprocessed_and_reused_flag": "N", "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": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20131104", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "562078", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131101", "brand_name": "DA VINCI S SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS2000 A5.1P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "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": [ "Difficult to Remove", "Device Dislodged or Dislocated" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250826", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20131101", "sequence_number_treatment": [ "DA VINCI S SURG SYSTEM INSTRUMENTS AND ACCESSORIE" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "69 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Capsular Contracture", "Fall", "Muscle Weakness/Atrophy", "Neurological Deficit/Dysfunction", "Pain", "No Code Available" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444213", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131004", "manufacturer_name": "", "report_source_code": "Manufacturer 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": "11245758", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT EXPERIENCED URINARY RETENTION, UNDERWENT SURGERY FOR A BALDDER NECK CONTRACTURE, AND REQUIRED A CYSTOSCOPY WITH REMOVAL OF A SMALL FOREIGN BODY AFTER UNDERGOING A DA VINCI S PROSTATECTOMY. THE LENGTH OF TIME IN LITHOTOMY POSITION DID NOT CONTRIBUTE SIGNIFICANTLY TO THE PATIENTS' UNDERLYING DEGENERATIVE SPINAL CONDITION. PROPER ROBOTIC SURGERY POSITIONING LIKE ANY OTHER OPERATION MAY TEMPORARILY CAUSE SYMPTOMS THAT WILL RESOLVE IN RECOVERY." }, { "mdr_text_key": "3856540", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI S PROSTATECTOMY FOR PROSTATE CANCER ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: FOLLOW UP NOTES THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION OF A LOST NEEDLE. THE NEEDLE BECAME DISLODGED INTO THE PATIENT AND CONVERSION TO AN OPEN LAPAROTOMY WAS REQUIRED ADDING 2 HOURS TO THE CASE. TOTAL OPERATING TIME WAS 10 HOURS. THE SURGEON NOTED IN THE OPERATIVE REPORT THAT AT AROUND THE 1 O'CLOCK POSITION THE NEEDLE SNAPPED FROM THE SUTURE. I ATTEMPTED TO GRAB THE SUTURE TO KEEP TENSION IN ORDER TO PLACE A LAPRATY TO COMPLETE THE ANASTOMOSIS, HOWEVER, DURING THIS, THE NEEDLE HAD FALLEN AND WAS OUT OF MY SIGHT. WE LOOKED FOR THE NEEDLE DEEP IN THE PELVIS IN THE AREA WHERE IT HAD BECOME DETACHED FROM THE SUTURE, HOWEVER, WE WERE UNSUCCESSFUL IN SEARCHING FOR IT. KNOWING THAT THE LAPAROSCOPIC VISION WITH THE CAMERA WAS SUPERIOR THAN OPENING, WE DID TAKE OUR TIME SEARCHING FOR THE NEEDLE. INTRAOPERATIVE FLUOROSCOPY/X-RAY WAS THEN CALLED AND THE NEEDLE WAS DEFINITELY SEEN IN THE PELVIS IN LINE WITH THE PUBIC SYMPHYSIS. MORE SEARCHING, WE PERFORMED AGAIN ANOTHER THOROUGH SEARCH, BUT WERE UNSUCCESSFUL IN FINDING THE NEEDLE. WE HAD SPENT OVER 2 HOURS BETWEEN SEARCHING AND X-RAY LOOKING FOR THIS SMALL RV1 NEEDLE. AT THAT POINT, THE CHIEF OF SURGERY WAS CALLED AND A GENERAL SURGEON WAS THEN CALLED IN TO HELP LOCATE THE NEEDLE. AN OPEN INCISION WAS MADE FROM THE UMBILICUS DOWN TO THE PUBIC SYMPHYSIS AND AFTER THE ROBOT WAS UNDOCKED AND REMOVED. ALL OF THE PORTS HAD BEEN REMOVED, AS WELL. WITH INTRAOPERATIVE FLUOROSCOPY, WE WERE ABLE TO LOCATE THE NEEDLE. AGAIN, THE LOCATION WAS AT THE PUBIC SYMPHYSIS, OR IN THE AREA OF THE PUBIC SYMPHYSIS. MULTIPLE MOSQUITO CLAMPS WERE THEN PLACED IN THE BELLY TO HELP AID US IN THE LOCATION (B)(6) THE SMALL NEEDLE. AFTER APPROXIMATELY 45 MINUTES, WE WERE ABLE TO LOCATE THE BUTT END OF THE NEEDLE DEEP INTO THE LEVATOR MUSCLE JUST TO THE RIGHT OF THE DORSAL VENOUS COMPLEX. THE PATIENT WAS DISCHARGED FROM HOSPITAL ON POST OP DAY 6 COMPLAINING OF RIGHT HIP PAIN THOUGHT TO BE DUE SOME COMPLICATION RELATED TO PROLONGED POSITIONING IN SURGERY. AT THE TIME OF DISCHARGE HE WAS AMBULATING HOWEVER WITH MILD DIFFICULTY. AN ABDOMINAL CT SCAN WAS PERFORMED WHICH SHOWED NO ABNORMALITY. WHILE AT HOME THE PATIENT CONTINUED TO HAVE RIGHT LEG WEAKNESS THAT CAUSED HIM TO FALL IN THE SHOWER. THE PATIENT PRESENTED TO AN EMERGENCY ROOM. A NEUROLOGICAL EXAM SUGGESTED A LUMBAR PLEXUS IRRITATION AND AN MRI WAS ORDERED WHICH RESULTED IN A DIAGNOSIS OF RADICULOPATHY ASSOCIATED WITH L3-L4 NARROWING. THE PATIENT TRIED VARIOUS REGIMENS OF ANALGESIA AND DECIDED UPON VALIUM AND PERCOCET. ON (B)(6) 2010, THE PATIENT WAS READMITTED FOR SURGERY DUE TO BLADDER NECK CONTRACTURE. THE PATIENT WAS BEGUN ON A REGIMEN OF OCCUPATIONAL AND PHYSICAL THERAPY WITH INCREASINGLY BENEFICIAL RESULTS. ON (B)(6) 2012 THE PATIENT WAS READMITTED TO THE HOSPITAL FOR SYMPTOMATIC URINARY RETENTION AND A CYSTOSCOPY WITH REMOVAL OF SMALL FOREIGN BODY WAS PERFORMED. A FOLEY CATHETER WAS PLACED FOR DRAINAGE AND A SMALL FOREIGN BODY WAS REMOVED. IT WAS NOT FELT TO HAVE CONTRIBUTED TO THE PATIENT'S COMPLAINTS. NO FURTHER INFORMATION WAS AVAILABLE." } ], "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": "" } ] }