{ "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) REVIEWED A JOURNAL ARTICLE BY TAKAHRIO YASUI ET AL TITLED, IMPACT OF PROSTATE WEIGHT ON PERIOPERATIVE OUTCOMES OF ROBOT-ASSISTED LAPAROSCOPIC PROSTATECTOMY WITH A POSTERIOR APPROACH TO THE SEMINAL VESICLE. ACCORDING TO THE REPORTED ARTICLE, FIVE PATIENTS EXPERIENCED INTRAOPERATIVE COMPLICATIONS, INCLUDING 3 PATIENTS WITH POSTERIOR BLADDER INJURY, 1 PATIENT WITH RECTAL INJURY, AND 1 PATIENT WITH ILEUM INJURY. IN ALL THESE PATIENTS, THE INJURY WAS REPAIRED DURING A ROBOTIC OPERATION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENTS. THE HOSPITALS NAME, DA VINCI SYSTEM SERIAL NUMBERS AND TYPE OF PROCEDURES INVOLVED WITH ALL FIVE COMPLAINTS WERE NOT INCLUDED IN THIS ARTICLE." }, { "mdr_text_key": "19457828", "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 FOR THE POST-OPERATIVE COMPLICATION EXPERIENCED BY ALL FIVE PATIENTS. THE JOURNAL ARTICLE DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED IN RELATION TO THE REPORTED EVENT. ISI CONTACTED THE AUTHOR OF THIS ARTICLE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENTS; THE AUTHOR MENTIONED THAT HE WAS UNABLE TO PROVIDE ISI ANY ADDITIONAL INFORMATION. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE JOURNAL ARTICLE INDICATED THAT FIVE PATIENT'S SUSTAINED INTRAOPERATIVE COMPLICATIONS DURING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, IT IS UNKNOWN HOW THESE FIVE PATIENTS REPORTED INJURIES OCCURRED. 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