{ "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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RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI S SUPRACERVICAL HYSTERECTOMY FOR FIBROID UTERUS AND MENORRHAGIA ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THE UTERUS WAS OF 14-16 WEEKS SIZE AND SIGNIFICANT ADHESIONS OF THE BLADDER TO THE CERVIX AND ANTERIOR PORTION OF THE UTERUS WERE ENCOUNTERED. THE ABDOMINAL FASCIA WAS NOTED TO HAVE A HERNIA DURING TROCAR PLACEMENT. THE URETERS WERE VISUALIZED BILATERALLY SHORTLY AFTER THE ROBOT WAS DOCKED. ADHESIONS WERE LYSED USING BOTH BLUNT AND SHARP DISSECTION. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION, NAMELY A 2CM CYSTOTOMY IN THE POSTERIOR WALL TOWARDS THE FLOOR OF THE BLADDER, FAR AWAY FROM THE TRIGONE, WHICH WAS REPAIRED BY A UROLOGIST USING A 2 LAYER REPAIR. INDIGO CARMINE WAS ADMINISTERED TO ENSURE BLADDER INTEGRITY. A SEPARATE CONSULTATION REPORT WAS PROVIDED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. THE DISCHARGE DATE WAS NOT PROVIDED. ON (B)(6) 2011, A CYSTOGRAM WAS PERFORMED WHICH REVEALED NO LEAKAGE OF CONTRAST FROM THE BLADDER. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE CYSTOGRAM REPORT." }, { "mdr_text_key": "17094698", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. 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 S SURGICAL PROCEDURE." } ], "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": "" } ] }