{ "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 INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2007. THE PROVIDED INFORMATION ALLEGES THAT THE PATIENT SUSTAINED A PUNCTURED BLADDER AND INCONTINENCE. THERE WAS NO SPECIFIC ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. NO OTHER INFORMATION WAS PROVIDED. INFORMATION RELATED TO THE DA VINCI SYSTEM WAS NOT PROVIDED; THEREFORE, THE MODEL AND SERIAL ARE NOT KNOWN." }, { "mdr_text_key": "11266070", "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. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL HYSTERECTOMY PROCEDURE." }, { "mdr_text_key": "24206674", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON OCTOBER 4, 2013 INTUITIVE SURGICAL RECEIVED ADDITIONAL INFORMATION AS PART OF A LEGAL DISPUTE REGARDING A PATIENT THAT UNDERWENT A NON-ROBOTIC TOTAL ABDOMINAL HYSTERECTOMY VIA LAPAROTOMY FOR CHRONIC PELVIC PAIN AND KNOWN EXTENSIVE PELVIC ADHESIONS ON (B)(6) 2007. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT . ADDITIONAL INFORMATION PROVIDED INCLUDES HAND WRITTEN POST-OP NOTE ON (B)(6) 2007 PATIENT UNDERWENT TOTAL ABDOMINAL HYSTERECTOMY WITH LSO AND LYSIS OF ADHESIONS VIA LAPAROTOMY. THERE WAS NO INDICATION THAT THE DA VINCI SURGICAL SYSTEM WAS USED FOR ANY PORTION OF THE PATIENT'S PROCEDURES." } ], "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": "11/02/2013" } ] }