{ "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 PARTIAL NEPHRECTOMY FOR L RENAL MASS ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES SUBSEQUENT OPERATIVE REPORTS: THERE WAS NOT AN INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY .THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION . POSTOPERATIVELY, THE PATIENT DEVELOPED OLIGURIA, ELEVATIONS IN CREATININE, AND FEVER. ON VENTILATOR FOR AN EXTENDED PERIOD OF TIME. ACUTE RENAL FAILURE ENSUED. RADIOLOGY CONSULTATION NOTES COLON PERFORATION SECONDARY TO ROBOTIC INTERVENTION. ALSO NOTED BY PATHOLOGY. ON (B)(6) 2010- EXPLORATORY LAPAROTOMY, LEFT COLECTOMY WITH END TRANSVERSE COLOSTOMY. ABDOMINAL WASHOUT FOR PERITONITIS. ON (B)(6) 2010 -CYSTOSCOPY WITH LEFT RETROGRADE PYELOGRAM AND DOUBLE J STENT PLACEMENT FOR A SMALL HOLE IN URETER DISCOVERED AT TIME OF BOWEL SURGERY. HAD TWO ROBOTIC INJURIES. DISCHARGED HOME ON (B)(6) 2010 AFTER A ONE MONTH ADMISSION. HOWEVER, NOT TO HOME- WAS SENT TO SKILLED NURSING." }, { "mdr_text_key": "11212214", "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 SI SURGICAL PROCEDURE. THE LIKELY CAUSE OF THIS INJURY IS ENTEROTOMY , A DIRECT ENTRY INJURY TO THE LARGE INTESTINE DURING ROBOTIC HANDLING OF THE BOWEL. DAMAGE TO THE URETER IS PROBABLY FOR THE SAME REASON." } ], "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": "" } ] }