{ "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": "2955842-2013-03201", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130826", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20111215", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "HEALTH PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Other", "Consumer" ], "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": "416749", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130826", "brand_name": "DA VINCI SI 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": "IS3000 A6.0P8", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20130826", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "30 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Wound Dehiscence", "Abdominal Pain", "Adhesion(s)", "Inflammation", "Scar Tissue", "Swelling" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3306739", "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": "3592081", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, ON JULY 25, 2013 INTUITIVE SURGICAL, INC. RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT THAT UNDERWENT A DA VINCI SI HYSTERECTOMY WITH DIAGNOSTIC CYSTOSCOPY ON (B)(6) 2011. THE PATIENT DEVELOPED POST -SURGICAL COMPLICATIONS ON (B)(6) 2012, THE PATIENT RETURNED TO THE OPERATING ROOM FOR AN ACUTE RIGHT ADNEXAL PAIN WITH A PELVIC MASS. A DIAGNOSTIC LAPAROSCOPY, RIGHT SALPINGO-OOPHORECTOMY, AND LYSIS OF ADHESIONS WERE PERFORMED FOR A HEMORRHAGIC RIGHT OVARIAN CYST AND ADHESIONS. THE SURGEON DESCRIBED MILD ADHESIONS OF THE BOWEL TO THE VAGINAL CUFF THAT AND SOME HEMORRHAGIC AREAS ON BOTH SIDES OF THE VAGINAL CUFF THAT WERE BIOPSIED. THE PATIENT'S SURGICAL PATHOLOGY REPORT WAS NOT AVAILABLE FOR REVIEW. ON (B)(6) 2012 THE PATIENT VISITED THE EMERGENCY ROOM WITH REPORTS OF SEVERAL HOURS OF ACUTE ONSET OF ABDOMINAL PAIN THAT OCCURRED DURING SEXUAL INTERCOURSE. A CT SCAN SHOWED AREAS OF PNEUMOPERITONEUM WITH FLUID IN THE PELVIS. THE PATIENT UNDERWENT A DIAGNOSTIC LAPAROSCOPY WITH DRAINAGE OF A PELVIC ABSCESS. IT WAS NOTED IN THE DIAGNOSTIC LAPAROSCOPY THAT THE RIGHT SIDE OF THE VAGINAL CUFF WAS FOUND TO BE OPEN WITH THE SMALL BOWEL PROTRUDING THROUGH THE VAGINAL CUFF. THE SURGEON CLOSED THE VAGINAL CUFF DEHISCENCE WHICH SHOWED INFLAMMATION ON THE VAGINAL CUFF AS WELL AS THE PERITONEAL SURFACES. AT THE END OF THE PROCEDURE THE SURGEON DOCUMENTED THAT THE VAGINAL CUFF APPEARED TO BE INTACT. ON (B)(6) 2012 THE PATIENT UNDERWENT A DIAGNOSTIC LAPAROSCOPY FOR CHRONIC PELVIC PAIN AND INTERSTITIAL CYSTITIS. UPON EXAMINATION THE SURGEON FOUND SCAR TISSUE, ENDOMETRIOSIS, AND GRANULATION TISSUE ON THE VAGINAL CUFF, WHICH WERE BIOPSIED AND SENT FOR PATHOLOGICAL REVIEW. THE SURGEON NOTED THAT THE LEFT OVARY WAS MULTI-CYSTIC WITH AN ENDOMETRIOMA, RESULTING IN A LEFT SALPINGO-OOPHORECTOMY. ON (B)(6) 2012, THE PATIENT UNDERWENT A PROCEDURE FOR VAGINAL CUFF DEHISCENCE REPAIR. THE SURGEON NOTICED AN AREA OF SEPARATION OF APPROXIMATELY 1 CM IN LENGTH; THE REMAINING VAGINAL CUFF WAS INTACT AND APPEARED STRONG. THE SURGEON NOTICED SUBSTANTIAL HEMORRHAGIC MATERIAL ADHERENT TO THE SMALL BOWEL IN THE POSTERIOR CUL-DE-SAC. ON (B)(6) 2012 THE PATIENT UNDERWENT A CYSTOSCOPY FOR CHRONIC PELVIC PAIN WITH INTERSTITIAL CYSTITIS. THE SURGEON NOTED THAT THE AREAS OF PETECHIAE, WHICH ARE SIGNS OF CYSTITIS IN THE BLADDER, WERE LESS THAN PREVIOUSLY. ON (B)(6) 2012, THE PATIENT WENT IN FOR SURGERY WHERE THE SURGEON PERFORMED AN EXPLORATORY LAPAROTOMY FOR CHRONIC PELVIC PAIN AND CHRONIC VAGINAL CUFF DEHISCENCE. THE SURGEON DESCRIBED THE VAGINAL CUFF AS HAVING HEMORRHAGIC MATERIAL AT THE RIGHT ANGLE, WHERE HER PAIN WAS LOCALIZED; THIS AREA WAS COMPLETELY REMOVED AND SENT FOR PATHOLOGIC EXAMINATION. SEVERAL AREAS OF ENDOMETRIOSIS WERE ALSO RESECTED OFF OF THE LEFT VAGINAL CUFF. ALL OF THE ABOVE SURGERIES WERE TOLERATED WELL WITH NO INTRAOPERATIVE COMPLICATIONS NOTED." }, { "mdr_text_key": "11066269", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE INTRA-OPERATIVE INJURY SUBSEQUENT POST-SURGICAL COMPLICATIONS EXPERIENCED 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 SURGICAL PROCEDURE." } ], "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": "" } ] }