{ "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) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGOOPHERECTOMY FOR OVARIAN SUPPRESSION DUE TO BREAST CANCER ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY]. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION NAMELY AN INADVERTENT CYSTOTOMY WHICH WAS REPAIRED PRIMARILY, AND DID NOT CONTRIBUTE TO THE SUBSEQUENT ADVERSE EVENT, NAMELY THE VAGINAL CUFF DEHISCENCE. ON (B)(6) 2011, THE PATIENT NOTED AN EPISODE OF PAIN AND VAGINAL BLEEDING AND WAS FOUND TO HAVE A VAGINAL CUFF DEHISCENCE AND SOME DEGREE OF EVISCERATION (RECORDS ARE HANDWRITTEN). THIS WAS REPAIRED VIA LAPAROTOMY ON (B)(6) 2011 THE PATIENT PRESENTED WITH SYMPTOMS OF VAGINAL BLEEDING AND WAS FOUND TO HAVE A 1CM AREA AT THE TOP OF THE VAGINA THAT WAS OPENING AGAIN. THIS WAS CALLED A DEHISCENCE AND THE PATIENT WAS TAKEN ONCE AGAIN FROM A LAPAROTOMY. MESH WAS PLACED AT THE TOP OF THE VAGINA TO HOPEFULLY PREVENT ANOTHER SIMILAR INCIDENT." }, { "mdr_text_key": "16250057", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE. THIS PATIENT HAD A CUFF DEHISCENCE WITH RECURRENCE IN PART DUE TO HORMONAL STATUS. CONTRIBUTION OF THE DAVINCI SURGICAL TECHNIQUE IS CONSIDERED. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT." } ], "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": "" } ] }