{ "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) 2012 FOR FIBROIDS, ABNORMAL PAP SMEAR, CHRONIC PAIN, AND PELVIC ADHESIONS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED CT SCAN, AND DISCHARGE SUMMARY FROM HOSPITAL READMISSION. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY OPERATION. THERE WAS A REMARK IN THE OPERATIVE NOTE SUGGESTING AN INTRAOPERATIVE BOWEL INJURY BUT NO ACTION WAS TAKEN. THE PATIENT WAS DISCHARGED THE DAY AFTER SURGERY BUT RETURNED TO THE HOSPITAL ON (B)(6) 2012 WITH COMPLAINTS OF FEVER, PAIN AND FOUL DISCHARGE. A CT SCAN SHOWED A PELVIC ABSCESS. SHE HAD A JACKSON PRATT DRAIN PLACED THROUGH THE VAGINA INTO THE ABSCESS CAVITY; SHE WAS GIVEN ANTIBIOTICS AND DISCHARGED ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE." }, { "mdr_text_key": "11242130", "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 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. 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