{ "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 A SUMMARY OUTLINE OF THE PATIENT'S MEDICAL RECORDS AND INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE AND LYSIS OF ADHESIONS PROCEDURE ON (B)(6) 2012. NO COMPLICATIONS DURING THE PROCEDURE WERE NOTED TO HAVE OCCURRED. ON (B)(6) 2012 THE PATIENT WAS ADMITTED THROUGH THE HOSPITAL'S EMERGENCY ROOM WITH COMPLETE VAGINAL PROLAPSE. ON (B)(6) 2013 THE PATIENT UNDERWENT A DIAGNOSTIC LAPAROSCOPY PROCEDURE WITH THE DA VINCI SURGICAL SYSTEM AND IT WAS FOUND TO HAVE MULTIPLE INTESTINAL ADHESIONS, A PELVIC ABSCESS AND VAGINAL CUFF DEHISCENCE. THE SURGICAL PROCEDURES PERFORMED INCLUDED ENTEROLYSIS-LYSIS OF THE ADHESIONS, EVACUATION OF THE ABSCESS, AND REPAIR OF THE VAGINAL CUFF DEHISCENCE. THE PATIENT'S APPENDIX AND SMALL BOWEL WERE ALSO INSPECTED BY A UROLOGIST CONSULTANT AND AT THE TIME OF THE SURGICAL PROCEDURE AND IT WAS REPORTEDLY DETERMINED BY THE SURGEON THAT NO OTHER PROCEDURES WERE REQUIRED. THE PROCEDURE WAS COMPLETED AND THERE WERE NO COMPLICATIONS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. IT WAS NOTED IN THE PATIENT'S DISCHARGE SUMMARY THAT THE PATIENT'S POST-OPERATIVE COURSE WAS UNREMARKABLE. NO OTHER INFORMATION WAS PROVIDED." }, { "mdr_text_key": "11017442", "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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI HYSTERECTOMY AND LYSIS OF ADHESIONS 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": "" } ] }