{ "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 FDA VOLUNTARY REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: UNDERWENT ROBOTIC -DA VINCI- PROCTECTOMY. RECTUM WAS PERFORATED AND NOT DETECTED UNTIL SEPSIS INFECTION HAD DEVELOPED REQUIRING EXTENDED HOSPITAL STAY AND NUMEROUS SURGERIES TO CLEAN OUT THE INFECTION AND PERFORM A COLOSTOMY." }, { "mdr_text_key": "11222725", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THE VOLUNTARY REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ISI HAS ATTEMPTED TO CONTACT 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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