{ "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. 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(ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THESE COMPLICATIONS ARE ACCEPTED RISKS OF PELVIC SURGERY AND APPEAR TO BE UNRELATED TO THE USE OF THE DA VINCI. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE." }, { "mdr_text_key": "3947818", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI S TOTAL HYSTERECTOMY AND SACROCOLPOPEXY FOR PELVIC ORGAN PROLAPSE ON (B)(6) 2013. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES HOSPITAL REPORTS AND OFFICE NOTES 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. ON (B)(6) 2013 THE PATIENT UNDERWENT ROBOTIC HYSTERECTOMY AND SACRAL COLPOPEXY. ON (B)(6) 2013 ER VISIT FOR PELVIC PAIN. DEVELOPMENT OF ABDOMINAL WALL ABSCESS WHICH WAS DRAINED AND A WOUND VAC WAS APPLIED. A RECTOVAGINAL FISTULA WAS SUSPECTED AND MANAGED CONSERVATIVELY. SHE WAS STARTED ON TPN NUTRITION (B)(6) 2013 AND WAS DISCHARGED ON (B)(6) 2013. PATIENT HAD WOUND CARE FOR SEVERAL MONTHS AND COMPLETED CASE IN (B)(6) 2013." } ], "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": "" } ] }