{ "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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RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI RIGHT ANTEGRADE PERCUTANEOUS URETEROSCOPY WITH STONE MANIPULATION (NON-ROBOTIC) FOLLOWED BY A ROBOTIC-ASSISTED BILATERAL URETERO NEOCYSTOSTOMIES WITH BILATERAL URETERAL STENT PLACEMENTS AND RIGHT PSOAS HITCH FOR REPAIR OF A PRIOR URETERAL INJURY ON (B)(6) 2011. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THE LEFT URETER WAS INADVERTENTLY CUT AND SUBSEQUENTLY REPAIRED BY THE SURGEON. THE PATIENT WAS DISCHARGED TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WAS A REPORT OF A POST-OPERATIVE COMPLICATION, SPECULATED TO BE THE RESULT OF PATIENT ARM POSITION DURING THE 7 1/2 HOUR PROCEDURE. UPON WAKING UP FROM THE SURGERY ON (B)(6) 2011 THE PATIENT PRESENTED WITH BLISTERING AND UPPER EXTREMITY PAIN THAT WAS SIGNIFICANTLY REDUCED IN THE HOURS FOLLOWING THE PROCEDURE. COMPARTMENT SYNDROME, WHILE INITIALLY SUSPECTED, WAS SUBSEQUENTLY RULED OUT. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF THE SURGERY." }, { "mdr_text_key": "11100431", "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." } ], "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": "" } ] }