{ "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 WHO UNDERWENT A DA VINCI SI HYSTERECTOMY FOR MENORRHAGIA, DYSMENORRHEA, AND PELVIC PAIN ON (B)(6) 2012. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. OTHER CONSULTANTS NOTES ARE INCLUDED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION SPECIFICALLY, A NARROWING OF THE RIGHT URETER POST PROCEDURE REQUIRING AN INTRA-OPERATIVE CONSULTATION FROM A UROLOGIST WHO WAS ABLE TO PASS A GLIDEWIRE AND A RIGHT URETERAL STENT PAST THE POINT OF NARROWING INTO THE RIGHT KIDNEY. THE PATIENT THEN HAD TO LEAVE THE STENT IN PLACE AND RETURN AT 6 WEEKS TO HAVE IT REMOVED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012." }, { "mdr_text_key": "16709451", "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 INTRA-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DID NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED AN INTRA-OPERATIVE COMPLICATION." } ], "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": "" } ] }