{ "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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ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, HE WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. THE SURGEON REPORTEDLY INFORMED THE INITIAL REPORTER THAT NO MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IN ADDITION, THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS. ON AN UNSPECIFIED DATE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. APPROXIMATELY TWO DAYS LATER, THE PATIENT PRESENTED TO THE HOSPITAL WITH UPPER QUADRANT PAIN. THE PATIENT WAS FOUND TO HAVE A BILE LEAK. THE SURGEON INDICATED THAT SHE DID NOT EXPERIENCE ANY ISSUES WITH THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT USED DURING THE CASE." }, { "mdr_text_key": "12603918", "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 COMPLICATION EXPERIENCED BY THE PATIENT. THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE OR CAUSED/CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE COMPLICATION. ISI HAS ATTEMPTED TO CONTACT THE SURGEON AND 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. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2014 REVEALED THAT NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE COMPLICATION. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI SINGLE-SITE CHOLECYSTECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED A BILE LEAK. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATION IS UNKNOWN." } ], "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": "" } ] }