{ "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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INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2009, THE PATIENT UNDERWENT ROBOTIC SACROCOLPOPEXY, LYSIS OF ADHESIONS AND SLING PROCEDURE WITH CYSTOSCOPY. DURING PROCEDURE IT WAS NOTED THAT THERE WAS MULTIPLE ADHESIONS AND A GENERAL SURGEON CAME AND TOOK DOWN ADHESIONS. IN RECOVERY, THE PATIENT DEVELOPED SEVERE HYPOTENSION, HAD LARGE BLOODY EMESIS AND WAS FOUND TO HAVE AN ACTIVELY BLEEDING STOMACH ULCERATION. THE PATIENT DEVELOPED ACUTE TUBULAR NECROSIS (ATN), HAD A COAGULOPATHY, BECAME SEPTIC, BUT ULTIMATELY WAS TREATED AND STABILIZED IN ICU. ON (B)(6) 2009, ADDITIONALLY THE PATIENT UNDERWENT A RIGHT HEMICOLECTOMY FOR ISCHEMIC BOWEL INJURY. THE PATIENT WAS DISCHARGED ON (B)(6) 2009. NO FURTHER CLINICAL INFORMATION WAS PROVIDED." }, { "mdr_text_key": "11098758", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST- SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE OPERATIVE REPORT INDICATED THAT AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE THE PATIENT SUFFERED POST -SURGICAL COMPLICATIONS." } ], "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": "" } ] }