{ "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 THE OPERATIVE REPORT AND MEDICAL RECORDS FROM THE ATTORNEY REPRESENTING THE PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY ON (B)(6) 2012. THE PATIENT'S PRE-OPERATIVE DIAGNOSIS WAS PELVIC PAIN AND MENORRHAGIA. BASED ON THE OPERATIVE SUMMARY, THE PATIENT WAS FOUND TO HAVE AN ENLARGED UTERUS APPROXIMATELY 14 WEEKS IN SIZE AND SEVERE, DENSE, AND EXTENSIVE ADHESIONS FROM THE BOWEL AND OMENTUM TO THE ANTERIOR ABDOMINAL WALL. THE SURGEON NOTED ON THE OPERATIVE SUMMARY THAT THE PATIENT SUSTAINED AN INTRA-OPERATIVE COMPLICATION RELATED TO AN ENTEROTOMY IN THE SMALL BOWEL MEASURING APPROXIMATELY 3 MM. THE CAUSE OF THE ENTEROTOMY WAS NOT PROVIDED IN THE OPERATIVE SUMMARY. ACCORDING TO THE OPERATIVE SUMMARY, REPAIR OF THE ENTEROTOMY WAS PERFORMED. THE DETAILS OF THE PROCEDURES WERE NOT PROVIDED. THE COMPLETE OPERATIVE REPORT WAS NOT PROVIDED. ON (B)(6) 2012, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, AND A SMALL BOWEL RESECTION PROCEDURE WITH REANASTOMOSIS. ACCORDING TO THE OPERATIVE SUMMARY 600 ML OF DARK FLUID WAS FOUND IN THE PATIENT'S ABDOMEN IN ADDITION TO A PERFORATION OF THE ILEUM MEASURING APPROXIMATELY 3-4 MM IN LENGTH. SEVERE, DENSE ADHESIONS OF BOWEL-TO-BOWEL WERE ALSO OBSERVED. THE DETAILED OPERATIVE REPORT WAS NOT PROVIDED. NO ADDITIONAL INFORMATION/MEDICAL RECORDS WERE PROVIDED." }, { "mdr_text_key": "20486237", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATION(S) EXPERIENCED BY THE PATIENT. THE INFORMATION RECEIVED DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. INTUITIVE SURGICAL INC. (ISI) HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: A PATIENT'S ATTORNEY ALLEGED A BOWEL PERFORATION INJURY AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE." }, { "mdr_text_key": "19918853", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON SEPTEMBER 5, 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012, AND ALLEGED A BOWEL PERFORATION INJURY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME." } ], "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": "11/01/2013" } ] }