{ "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": "2955842-2013-03130", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120508", "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": "20130823", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "409534", "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 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": "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": [ "Device Operates Differently Than Expected" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "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": "1", "date_received": "20130823", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "40 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Wound Dehiscence", "Tissue Damage" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305439", "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": "3587999", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH SALPINGO-OOPHORECTOMY ON (B)(6) 2012. THE DOCUMENTATION RECEIVED STATES THAT THE PATIENT SUSTAINED VAGINAL DEHISCENCE AND PARTIAL EVISCERATION. ACCORDING TO THE LEGAL COMPLAINT, THE PATIENT WAS FOUND TO HAVE ADENOMYOSIS AND COLON ADHESIONS DURING THE SURGICAL PROCEDURE. A POST-OPERATIVE CYSTOSCOPY WAS FOUND TO BE NORMAL. THE LEGAL COMPLAINT ALSO INDICATED THAT THE SURGEON LATER NOTED IN AN OFFICE NOTE THAT SHE HAD TAKEN EXTRA CARE TO TAKE WIDE BITES OF TISSUE WITH CUFF CLOSURE DUE TO PATIENT HISTORY OF HEAVY SMOKING. THE PATIENT WAS REPORTEDLY DISCHARGED HOME IN STABLE CONDITION ON THE FIRST POST-OPERATIVE DAY. THE PATIENT WAS FOUND TO HAVE NO COMPLICATIONS DURING A POST-OPERATIVE FOLLOW-UP VISIT ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT WAS REPORTEDLY ADMITTED TO A HOSPITAL FOR A VAGINAL CUFF DEHISCENCE AND PARTIAL EVISCERATION. THE PATIENT UNDERWENT AN OPEN EXPLORATORY LAPAROTOMY WITH CLOSURE OF THE VAGINAL CUFF. THE INFORMATION RECEIVED STATED THE PATIENT HAS RECOVERED AND APPEARS TO BE DOING WELL. NO ADDITIONAL INFORMATION IS AVAILABLE." }, { "mdr_text_key": "11011921", "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 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. ISI HAS REVIEWED THE SYSTEM LOGS OF THE SITE WITH A PROCEDURE DATE OF (B)(4) 2012. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED VAGINAL CUFF DEHISCENCE AND PARTIAL EVISCERATION AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE." }, { "mdr_text_key": "11217158", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI ROBOTIC HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES PATHOLOGY REPORT, DISCHARGE SUMMARY, CYSTOSCOPY REPORT, FOLLOW UP MEDICAL NOTES AND FINDINGS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. THE PATIENT HAD POST-OP VISITS WITH HER PHYSICIAN. HIS OFFICE NOTES INDICATE SHE WAS GIVEN TREATMENT FOR VAGINITIS AND BEGUN ON HORMONE REPLACEMENT OF VARYING DOSAGE. ON (B)(6) 2012, THE PATIENT HAD A PELVIC EXAM SHOWING SUTURES STILL VISIBLE IN THE VAGINA. ON (B)(6) 2012, THE PATIENT PRESENTED WITH PAIN AFTER FIRST INTERCOURSE AND VAGINAL BLEEDING. SHE WAS FOUND TO HAVE VAGINAL CUFF DEHISCENCE WITH BOWEL IN THE UPPER VAGINA. SHE UNDERWENT EXPLORATORY LAPAROTOMY WITH REFRESHING OF THE EDGES OF THE VAGINA AND VAGINAL RESUTURING WITH 0 PDS SUTURE. PHYSICIAN OFFICE NOTES POST DEHISCENCE SHOW HE HAD BEEN CONCERNED ABOUT THE HEALING OF THE CUFF, AND WARNED THE PATIENT AGAINST SEXUAL ACTIVITY. THE PATIENT EXPERIENCED SEPARATION OF THE VAGINAL CUFF AFTER HER FIRST EPISODE OF INTERCOURSE POST-OPERATIVELY. THERE IS NO EVIDENCE PROVIDED THAT THE PATIENT HAD PERMISSION FROM HER PHYSICIAN TO RESUME FULL ACTIVITY DESPITE EVIDENCE OF SUTURE MATERIAL SEEN ON EXAM AND RECENT TREATMENT FOR VAGINAL INFECTION. THE PHYSICIAN WAS AWARE OF INCREASED DEHISCENCE RISK (FROM SMOKING, LOW HORMONE LEVELS), RECENT INFECTION) AND TRIED TAKING MEASURES TO PREVENT AND WARN AGAINST THIS COMPLICATION (180 DAY SUTURE, EXTRA WIDE SUTURING, INCREASED HORMONE DOSING). UNFORTUNATELY SEXUAL INTERCOURSE CAN FORCIBLY DISRUPT EVEN A NORMALLY HEALING VAGINAL CUFF." } ], "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": "11/01/2013" } ] }