{ "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 INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI RADICAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY, COLLECTION OF PERITONEAL CYTOLOGY AND PELVIC LYMPHADENECTOMY ON (B)(6) 2010. THE PATIENT HAD A PRE-OPERATIVE DIAGNOSIS OF GRADE 2 ENDOMETRIAL CARCINOMA. ACCORDING TO THE PATIENT'S OPERATIVE (OP REPORT) THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED. REPORTEDLY, AT THE END OF THE SURGICAL PROCEDURE, EXCELLENT HEMOSTASIS WAS NOTED AFTER CLOSURE OF THE PATIENT'S VAGINAL CUFF WAS COMPLETED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WERE NO COMPLICATIONS EXPERIENCED BY THE PATIENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010. REPORTEDLY DURING A POST-OPERATIVE EXAMINATION ON (B)(6) 2010, IT WAS DISCOVERED THAT THE PATIENT HAD A SLIGHT VAGINAL CUFF DEHISCENCE AT THE APEX AND ON THE SAME DAY, THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPAIR THE AFFECTED AREA. THERE WERE NO COMPLICATIONS EXPERIENCED BY THE PATIENT AND SHE WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ACCORDING TO THE MEDICAL CHARTS DATED (B)(6) 2010 THE PATIENT'S CUFF INCISION WAS FOUND TO BE INTACT. SINCE THE SURGERY ON (B)(6) 2010 THE PATIENT WENT THROUGH COMPLEX TREATMENT FOR HER CANCER, INCLUDING ADJUVANT RADIATION THERAPY AND MULTIPLE PROCEDURES RELATED TO HER ENDOMETRIAL CANCER." }, { "mdr_text_key": "11104505", "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 VAGINAL CUFF DEHISCENCE 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. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED VAGINAL CUFF DEHISCENCE FOLLOWING A DA VINCI SI HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY, COLLECTION OF PERITONEAL CYTOLOGY AND PELVIC LYMPHADENECTOMY." } ], "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": "" } ] }