{ "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": "2955842-2013-03186", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130111", "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": "20130826", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "409680", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130823", "brand_name": "DA VINCI SI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT", "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": "IS3000 A6.0P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250810", "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": "20130823", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "28 YR", "patient_sex": "", "patient_weight": "54", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Abscess", "Adhesion(s)", "Fever", "Inflammation", "Nausea", "Pain", "Seroma", "Vomiting", "Discharge", "Anxiety", "Vascular Dissection", "No Code Available", "Constipation" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3306222", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130725", "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": "11070511", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED IN THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE INJURY SUSTAINED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP AT THE SITE, HOWEVER, AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI HYSTERECTOMY PROCEDURE." }, { "mdr_text_key": "3586210", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, ON (B)(4) 2013, INTUITIVE SURGICAL, INC. RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2013. THE OPERATIVE (OP) REPORT FOR THE PATIENT'S HYSTERECTOMY PROCEDURE ON (B)(6) 2013 WAS NOT PROVIDED. THE PATIENT'S MEDICAL SUMMARY ALLEGES THAT THE PATIENT UNDERWENT THE DA VINCI HYSTERECTOMY PROCEDURE SECONDARY TO FAILED MEDICAL MANAGEMENT OF DYSMENORRHEA AND MENORRHAGIA. THE SURGICAL PROCEDURE WAS APPARENTLY COMPLICATED DUE TO DENSE PELVIC ADHESIONS. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITH HER POSTOPERATIVE COURSE COMPLICATED BY PANIC ATTACK. POST OPERATIVELY THE PATIENT REPORTED THAT SHE HAD SOME RIGHT SHOULDER PAIN AS WELL AS BLOATING AND WAS MANAGED CONSERVATIVELY WITH REST, HYDRATION AND STOOL SOFTENERS, HOWEVER, HER PAIN WORSENED. THE PATIENT'S MEDICAL REPORTS PROVIDED STATE THAT WHEN THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2013, THE PATIENT DESCRIBED HER PAIN AS BEING SO INTENSE THAT SHE COULD NOT EAT OR DRINK. THE PATIENT ALSO REPORTED FEVER AND VOMITING. ABDOMEN AND PELVIC CT TESTS WERE ORDERED. NO SIGNIFICANT INTRA-ABDOMINAL FINDINGS NOTED. IN THE RIGHT ADNEXA, MULTI-CYSTIC COLLECTION WAS SEEN. THE PATIENT ALSO REPORTED CONSTIPATION AND STOOL SOFTER WAS PRESCRIBED. ON (B)(6) 2013, THE PATIENT WAS READMITTED DUE TO FEVER AND ABDOMINAL PAIN. SHE CONSENTED FOR A DIAGNOSTIC LAPAROSCOPY. DURING THE SURGICAL PROCEDURE THE PATIENT'S VAGINAL CUFF WAS FOUND TO BE INTACT; HOWEVER, THERE WAS SOME GREENISH DISCHARGE COMING FROM THE CUFF. A MANUAL EXAMINATION FOUND THAT THE PATIENT HAD A LARGE IMMOBILE MASS IN THE RIGHT LOWER QUADRANT APPROXIMATELY 6CM. UNDER DIRECT VISUALIZATION MULTIPLE DENSE ADHESIONS OF THE MENTUM AND BOWEL TO THE ANTERIOR ABDOMINAL WALL WERE DISCOVERED. DURING TAKE DOWN OF THE PATIENT'S ADHESIONS, THE SURGEON MADE THE DECISION TO CONTINUE DISSECTION USING TRADITIONAL LAPAROTOMY TECHNIQUES TO SAFELY TAKE DOWN THE PATIENT'S ADHESIONS, SINCE THE PATIENT'S BOWEL HAD ADHERED TO THE ANTERIOR ABDOMINAL WALL. DURING THE SURGICAL PROCEDURE IT WAS DISCOVERED THAT THE PATIENT HAD AN INFLAMED BOWEL WITH SOME SEROSAL DENUDATION AND A PELVIC CUFF ABSCESS. THE ABSCESS WAS EVACUATED. EXAMINATION OF THE PATIENT'S BOWEL FOUND SEVERAL AREAS OF SEROSAL INFLAMMATION. A GENERAL SURGEON WAS CONSULTED AND THE DECISION WAS MADE TO MANAGE THE CONDITION WITH BOWEL REST. NO REPAIR WAS REQUIRED. THE PATIENT'S ABDOMEN WAS THEN COPIOUSLY IRRIGATED AND A JACKSON PRATT DRAIN WAS PLACED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE POST-ANESTHESIA CARE UNIT IN STABLE CONDITION. ON (B)(6) 2013, THE PATIENT DISCHARGED HERSELF FROM THE HOSPITAL AGAINST THE ADVICE OF THE NURSING STAFF. THE PATIENT'S MEDICAL SUMMARY ALLEGES THAT ON (B)(4) 2013, THE PATIENT RETURNED TO URGENT CARE COMPLAINING OF ABDOMINAL PAIN WITH NAUSEA AND VOMITING. WHEN THE PATIENT WAS INFORMED THAT SHE HAD SIGNED HERSELF OUT OF THE HOSPITAL AGAINST THE HOSPITAL ADVICE, THE PATIENT STATED THAT SHE DID NOT KNOW WHAT SHE WAS DOING AND DID NOT REALIZE THAT SHE WAS AT HOME UNTIL AWAKENED AT HOME. DURING A POST-OPERATIVE FOLLOW-UP AND EXAMINATION THE PATIENT'S ABDOMINAL INCISION WAS FOUND TO BE WELL HEALED AND THE STAPLES WERE REMOVED. A FOLLOW-UP EXAMINATION ON (B)(4) 2013, FOUND THAT THE PATIENT WAS DOING WELL, HAD NONSPECIFIC GI ISSUES AND PAIN THAT WAS CONSISTENT WITH POST-OPERATIVE RECOVERY. THE PATIENT HAD VOICED CONCERNS REGARDING THE POST-SURGICAL COMPLICATIONS SHE EXPERIENCED. IT WAS EXPLAINED TO THE PATIENT THAT THE POST-SURGICAL COMPLICATIONS SHE EXPERIENCED WERE LIKELY SECONDARY TO THE EXTENSIVE DISSECTIONS DUE TO HER SCAR TISSUE AND WAS UNRELATED TO THE DA VINCI SURGICAL TECHNOLOGY. ON (B)(6) 2013, DURING A FOLLOW-UP EXAMINATION IT WAS DISCOVERED THAT THE PATIENT WAS WELL HEALED. ON (B)(6) 2013, DURING A ROUTINE FOLLOW-UP PELVIC EXAM, THE PATIENT WAS HEALING WELL AND HER PAIN WAS CONTROLLED. THE PATIENT HAD NO ACTIVE ISSUES." } ], "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": "03/10/2015" } ] }