{ "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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THE PATIENT REPORTED THAT SHE WAS TO UNDERGO A DA VINCI SURGICAL PROCEDURE TO REMOVE THE CYST, HOWEVER, 3 DAYS PRIOR TO THE PLANNED SURGICAL PROCEDURE, THE CYST BURST. POST OPERATIVELY THE PATIENT EXPERIENCED PAIN AND WAS TOLD BY THE ATTENDING NURSE THAT DR (B)(6) PERFORMED AN APPENDECTOMY (DUE TO ENDOMETRIOSIS AND CHRONIC APPENDICITIS) AND A CYSTECTOMY. REPORTEDLY THE PATIENT WAS NOT AWARE THAT SHE HAD ANY OTHER CYSTS EXCEPT FOR THE CYST THAT RESOLVED ITSELF. THE PATIENT WAS PRESCRIBED AN ANTIBIOTIC, NAUSEA SUPPOSITORIES AND PAIN MEDICATIONS AND RELEASED FROM THE HOSPITAL ON (B)(6) 2011. THE PATIENT INDICATED THAT SHE EXPERIENCED EXTREME NAUSEA AND VOMITING 2 DAYS POST OP AND ON (B)(6) 2011, SHE CONTACTED DR (B)(6) HOWEVER, DR (B)(6) WAS NOT AVAILABLE. THE PATIENT INDICATED THAT ON (B)(6) 2011 WENT TO THE (B)(6) EMERGENCY ROOM AND IT WAS DISCOVERED THAT THE PATIENT WAS SEPTIC AND WAS LOOSING BLOOD. THE PATIENT INDICATED THAT ON (B)(6) 2011 THE PATIENT UNDERWENT A 2ND SURGICAL PROCEDURE TO SUCTION THE BLOOD OUT OF HER PELVIC CAVITY AND THE SURGEON DISCOVERED THAT THE PATIENT'S RIGHT OVARIAN LIGAMENT WAS TORN DURING THE FIRST SURGICAL PROCEDURE. THE PATIENT INDICATED THAT THE SURGEON WHO PERFORMED THE 2ND PROCEDURE INDICATED THAT THERE WAS NO OBVIOUS CYSTECTOMY PERFORMED AND THAT A BILATERAL OVARIAN DRILLING PROCEDURE WAS PERFORMED." }, { "mdr_text_key": "10190316", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED BY THE PATIENT, IT IS INDETERMINABLE IF THE DA VINCI SI SYSTEM, INSTRUMENTS AND/OR ACCESSORIES CAUSED OR CONTRIBUTED TO THE POST SURGICAL COMPLICATIONS. A REVIEW OF THE SYSTEM LOGS SHOWED NO SYSTEM MALFUNCTION OCCURRED DURING THE PROCEDURE PERFORMED ON (B)(6) 2011. ISI HAS CONTACTED THE RISK MANAGEMENT DEPARTMENT AT (B)(6) MEDICAL CENTER 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." } ], "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": "" } ] }