{ "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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REPORTEDLY, THE PATIENT UNDERWENT A SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES TO REPAIR THE AFFECTED AREA." }, { "mdr_text_key": "10635173", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THIS EVENT. THE CSR INDICATED THAT HE WAS PRESENT DURING THE ENTIRE SURGICAL PROCEDURE AND THAT HE DID NOT OBSERVE ANY MALFUNCTION OF THE SITE'S DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES. THE CSR INDICATED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WERE NO INTRA-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THE CSR INDICATED THAT AFTER COMPLETION OF THE SURGICAL PROCEDURE, THE SURGEON INDICATED TO HIM THAT HE (SURGEON) FELT THAT THE SURGERY WENT WELL. THE CSR INDICATED THAT HE SPOKE TO THE HOSPITAL'S HOUSE PHYSICIAN CONCERNING THIS EVENT AND THE HOUSE PHYSICIAN INDICATED TO HIM THAT THE DAMAGE FOUND TO THE PATIENT'S BOWEL WAS A CLEAN CUT AND DID NOT HAVE THE APPEARANCE OF DAMAGE CAUSED BY CAUTERY ENERGY. THE CSR INDICATED THAT HE ALSO SPOKE TO THE SURGEON REGARDING THIS EVENT. PER THE CSR, THE SURGEON INDICATED TO HIM THAT IT IS UNKNOWN IF DAMAGE TO THE PATIENT'S BOWEL OCCURRED DURING CREATION OF THE PORT SITE INCISION OR IF THE PATIENT INJURY OCCURRED DURING THE SURGICAL PROCEDURE. THE CSR INDICATED THAT THE SURGEON INDICATED TO HIM THAT THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AND IS RECOVERING. NO OTHER DETAILS CONCERNING THE PATIENT WERE PROVIDED BY THE SURGEON. ISI HAS CONCLUDED THAT BASED ON THE INFORMATION PROVIDED BY THE SITE, THE ROOT CAUSE OF THE BOWEL INJURY SUSTAINED BY THE PATIENT IS INDETERMINABLE. IF ISI RECEIVES ADDITIONAL INFORMATION CONCERNING THIS EVENT, A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA." } ], "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": "" } ] }