{ "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": "2955842-2013-03185", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120413", "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": "409763", "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": "", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250813", "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": [ "DAV SI SURG SYS. INSTRUMENTS, ACCESSORIES & ESU" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "37 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Nausea", "Pain", "Perforation", "Vomiting", "Rupture", "Discharge", "Extubate" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3306200", "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": "17615995", "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 RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE, A CYSTOSCOPY AND LYSIS OF ADHESION PROCEDURE ON (B)(6) 2012. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012 IN STABLE CONDITION. ON (B)(6) 2012, THE PATIENT RETURNED TO THE HOSPITAL'S EMERGENCY ROOM COMPLAINING OF ABDOMINAL PAIN. THE PATIENT'S OPERATIVE (OP) REPORT FOR THE SURGICAL PROCEDURE DATED (B)(6) 2012 INDICATED THAT THE PATIENT'S PREOPERATIVE DIAGNOSIS WAS CHRONIC PAIN AND ABNORMAL VAGINAL BLEEDING. THE OP REPORT DID NOT ALLEGE THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE AND THERE WERE NO ANOMALIES NOTED. PER THE INFORMATION IN THE OP REPORT, THE SURGICAL PROCEDURE WAS COMPLETED AND THE PATIENT TOLERATED THE PROCEDURE WELL. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT CALLED THE DOCTOR'S OFFICE ON (B)(6) 2012 COMPLAINING OF NAUSEA AND VOMITING. AN E-SCRIPT FOR ZOFRAN WAS SENT IN FOR HER. ON (B)(6) 2012, THE PATIENT UNDERWENT A CYSTOSCOPY, BILATERAL RETROGRADE URETEROGRAM, BILATERAL DOUBLE URETERAL STENT PLACEMENT AND THEN A ROBOTIC-ASSISTED LAPAROSCOPIC BLADDER REPAIR AND CLOSURE. DURING THE CYSTOSCOPY PROCEDURE IT WAS DISCOVERED THAT THE PATIENT HAD A 1 CM BLADDER RUPTURE OR PERFORATION. BILATERAL RETROGRADE URETEROGRAMS PERFORMED FOUND THAT THE BILATERAL COLLECTING SYSTEM APPEARED TO BE NORMAL. A ROBOTIC-ASSISTED BLADDER REPAIR WAS PERFORMED AND THE PROCEDURE WAS COMPLETED AND THE BLADDER WAS CAREFULLY EVALUATED WHICH SHOWED NO OTHER INJURY. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS EXTUBATED AND TRANSFERRED TO THE POST ANESTHESIA CARE UNIT IN STABLE CONDITION. THERE WERE NO SURGICAL COMPLICATIONS. THE OP ALLEGES THAT THE PATIENT WAS DISCHARGED IN STABLE CONDITION ON (B)(6) 2012. ON (B)(6) 2012, DURING FOLLOW UP EXAMINATION, THE PATIENT COMPLAINED OF ABDOMINAL PAIN AND NAUSEA APPROXIMATELY 30 MINUTES AFTER EATING. AN EXAMINATION OF THE PATIENT'S ABDOMEN FOUND THAT THE PATIENT DID NOT HAVE CVA TENDERNESS AND THAT HER LAPAROSCOPIC INCISIONS WERE HEALING WELL. THE PATIENT'S ABDOMEN WAS SOFT AND HER BOWELS WERE ACTIVE. THERE WERE NO SIGNS OF ACUTE ABDOMEN OR REBOUND. ZOFRAN WAS PRESCRIBED TO PREVENT NAUSEA. ON (B)(6) 2012, THE PATIENT UNDERWENT A FOLLOW EXAMINATION. THE PATIENT COMPLAINED OF BACK PAIN DUE TO THE STENTS. THE PATIENT'S ABDOMEN WAS FOUND TO BE SOFT, NONTENDER AND NONDISTENDED. NO ORGANOMEGALY PALPABLE, NO HERNIAS AND THE INCISIONS WERE HEALING WELL. THE PATIENT HAD NO ERYTHEMA OR DISCHARGE. A PELVIC EXAMINATION FOUND THAT THE PATIENT'S URETHRA PALPATES WERE NORMAL AND THE VAGINA WAS WITHOUT LESIONS. PROLAPSE WAS NOTED. THE SUTURES WERE IN PLACE AND THE VAGINAL CUFF WAS INTACT. ON (B)(6) 2012 A FOLLOW UP EXAMINATION FOUND THAT THE PATIENT'S ABDOMEN WAS SOFT, NONTENDER AND NONDISTENDED. THE PATIENT HAD NO MASSES PALPABLE. NO ORGANOMEGALY PALPABLE. NO HERNIAS. ALL OF THE PATIENTS' INCISIONS WERE FOUND TO BE HEALING WELL AND SHE HAD NO ERYTHEMA OR DISCHARGE. THE PATIENT'S PELVIC EXAMINATION THE PATIENT'S EXTERNAL URETHRAL MEATUS APPEARED NORMAL AND THE URETHRA PALPATES WERE NORMAL. THE PATIENT'S VAGINA DID NOT EXHIBIT LESIONS AND NO PROLAPSE WAS NOTED. THE PATIENT'S CERVIX WAS SURGICAL ABSENT AND THE SUTURES WERE IN PLACE. THE PATIENT'S VAGINAL CUFF WAS COMPLETELY HEALED AND THERE WERE NO PELVIC MASSES NOTED. THERE WERE NO MASSES IN THE CUL-DE-SAC. THE PATIENT'S BLADDER WAS NONTENDER. THE PATIENT HAD NO INGUINAL LYMPHADENOPATHY. ON (B)(6) 2012, THE PATIENT UNDERWENT A FOLLOW-UP EXAMINATION. THE PATIENT'S PELVIC EXAMINATION FOUND THAT THE PATIENT WAS HEALING WELL. ON (B)(6) 2012 DURING A FOLLOW-UP EXAMINATION, SHE COMPLAINED OF DISCHARGE, PAINFUL INTERCOURSE AND DYSPAREUNIA, IT WAS DISCOVERED THAT THE PATIENT HAD A LITTLE 2 MM GRANULATION TISSUE. THIS WAS TREATED WITH SILVER NITRATE. NO PELVIC VINASSES AND THE BLADDER WAS NOT TENDER." }, { "mdr_text_key": "17672717", "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 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. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE OF (B)(6) 2012 FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED AN INJURY DURING A DA VINCI SURGICAL HYSTERECTOMY 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": "" } ] }