{ "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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THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. 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. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2013 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 COMPLICATIONS. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE EXPERIENCED POST-OPERATIVE COMPLICATIONS THAT REQUIRED SURGICAL REPAIR AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS IS UNKNOWN." }, { "mdr_text_key": "5200160", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2013, THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS. AFTER BEING RELEASED FROM THE HOSPITAL ON AN UNSPECIFIED DATE, THE PATIENT INDICATED THAT SHE EXPERIENCED PAIN, DISCOMFORT, A BLADDER INFECTION, AND FLUID DISCHARGE. ON (B)(6) 2013, THE PATIENT CLAIMED THAT HER INCISION BURST AND HER BOWEL CAME OUT. THE PATIENT WAS REPORTEDLY RUSHED TO AN EMERGENCY ROOM (ER) AND REPAIR OF THE POST-OPERATIVE COMPLICATIONS WAS PERFORMED. THE DA VINCI SURGICAL SYSTEM WAS NOT USED DURING REPAIR OF THE POST-OPERATIVE COMPLICATIONS. THE PATIENT DID NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT." }, { "mdr_text_key": "12647536", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON 01/05/2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S DIRECTOR OF RISK MANAGEMENT. THE DIRECTOR OF RISK MANAGEMENT CONFIRMED THAT THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE PERFORMED ON (B)(6) 2013. SHE WAS UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE PATIENT OR EVENT. THIS COMPLAINT WILL REMAIN REPORTABLE BASED ON THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE AND REQUIRED ADDITIONAL MEDICAL INTERVENTION. THE CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS 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": "01/09/2015" } ] }