{ "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 AN UF/IMPORTER REPORT (B)(4), WITH THE FOLLOWING EVENT DESCRIPTION: THE SURGEON ASKED FOR A UROLOGY CONSULT DUE TO A POSSIBLE THERMAL INJURY TO A URETER. A SECOND PHYSICIAN CAME IN AND CONFIRMED THERE WAS A URETERAL INJURY. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THE EVENT." }, { "mdr_text_key": "12041722", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE ROOT CAUSE OF THE URETERAL INJURY IS UNKNOWN AT THIS TIME. THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT OR AN ACCESSORY OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW- UP MDR WILL BE SUBMITTED. ISI CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. 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