{ "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 HYSTERECTOMY PROCEDURE ON (B)(6) 2009 FOR PELVIC PAIN, ENDOMETRIOSIS, AND IRREGULAR BLEEDING. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED HOSPITAL OPERATIVE, RADIOLOGY 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) 2009, THE PATIENT PRESENTED WITH SEVERE PAIN FOLLOWING INTERCOURSE (THE PATIENT HAD BEEN CLEARED TO RESUME THIS ACTIVITY) AND VAGINAL DISCHARGE. SHE WAS FOUND TO HAVE PARTIAL DEHISCENCE WITH EVISCERATION. ADHESIONS OF BOWEL TO CUFF NOTED. PATIENT WENT TO O.R. FOR CUFF CLOSURE. THE PATIENT REPORTED PAINFUL INTERCOURSE ON NOTES FROM (B)(6) 2010. SHE RETURNED TO THE OR FOR DIAGNOSTIC LAPAROSCOPY WITH FINDING OF VERY THIN AREA OF VAGINAL TISSUE." }, { "mdr_text_key": "11372104", "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 PATIENT'S PRIMARY COMPLICATION OF VAGINAL CUFF DEHISCENCE OCCURRED AFTER INTERCOURSE WITHIN 10 WEEKS AFTER HYSTERECTOMY. AFTER REPAIR, HER COMPLAINTS OF PAIN, MAY BE RELATED, IN PART, TO THE UNDERLYING PROBLEM OF PAIN WITH ENDOMETRIOSIS, CHRONIC PELVIC PAIN, AND ENTEROCOELE. THE PROCESS OF VAGINAL THINNING IS A FREQUENT PROBLEM IN GENERAL GYNECOLOGY AND MAY BE RELATED TO THE GENERAL ISSUES OF PELVIC ORGAN PROLAPSE WITH ADVANCING AGE. THE MEDICAL RECORDS 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." } ], "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": "" } ] }