BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBLATOR II SURGERY SYSTEM

    MDR report key: 2223989 · Received August 18, 2011

    Report

    Report Number
    2951580-2011-00111
    Event Type
    Death
    Date Received
    August 18, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 1, 2011
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K030108
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 1 OF 2. REFERENCE MANUFACTURER'S REPORT #: 2951580-2011-00112. THE LOT AND SERIAL NUMBERS FOR THE DEVICE WERE NOT AVAILABLE; THEREFORE, NO MANUFACTURING OR EXPIRATION DATE COULD BE DETERMINED AND NO DEVICE HISTORY RECORDS COULD BE REVIEWED. ATTEMPTS TO OBTAIN ADDITIONAL INFO REGARDING THE CAUSE OF THE PT'S DEATH WERE UNSUCCESSFUL. THERE IS NO ALLEGATION FROM A HEALTHCARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT UNDERWENT A TONSILLECTOMY AND A PARTIAL UVULECTOMY FOR THE TREATMENT OF SLEEP APNEA ON (B)(6) 2011. THE PROCEDURE WAS PERFORMED USING A COBLATOR II SURGERY SYSTEM AND AN EVAC 70 XTRA PLASMA WAND. THE SURGICAL PROCEDURE WAS UNEVENTFUL WITH NO REPORTED COMPLICATIONS ENCOUNTERED DURING OR IMMEDIATELY FOLLOWING THE PROCEDURE. FOLLOW UP WITH THE PHYSICIAN APPROX ONE WEEK LATER FOUND THAT THE PT WAS RELEASED, AT HER REQUEST, ON (B)(6) 2011. THE PT HAD EXPIRED AT HER HOME APPROX 15 HOURS POST-OPERATIVE. THE PHYSICIAN REPORTED THE PT'S BODY WAS DISCOVERED BY HER FAMILY. ALTHOUGH THERE WAS NO EVIDENCE OF ANY POST-OPERATIVE BLEEDING AT THE PT'S HOME, SHE WAS ALLEGEDLY FOUND WITH A FOAM-LIKE SUBSTANCE COMING FROM HER MOUTH. THE PHYSICIAN INDICATED THAT ASIDE FROM A LARYNGEAL SPASM DURING EXTUBATION, THE PT DID NOT EXHIBIT ANY COMPLICATIONS PRIOR TO HER DISCHARGE. AN AUTOPSY WAS PERFORMED ON (B)(6) 2011. ACCORDING TO THE PHYSICIAN, THE CORONER'S REPORT INDICATED THE FOSSAE AND LUNGS WERE CLEAR WITH NO SIGNS OF ABNORMALITIES. IN ADDITION, THE POST-MORTEM URINE TESTED POSITIVE FOR AN UNSPECIFIED SEDATIVE DRUG. THE PT'S FAMILY INDICATED THE PT HAD TAKEN SLEEPING PILLS THE NIGHT BEFORE THE SURGICAL PROCEDURE. IT IS UNK IF THE PT HAD DISCLOSED THIS INFO TO THE PHYSICIAN PRIOR TO THE PROCEDURE. THE CAUSE OF DEATH WAS REQUESTED, HOWEVER, THE PHYSICIAN DECLINED TO RELEASE THAT INFO. THE PHYSICIAN DISCLOSED THAT HE DID NOT FEEL THE PT'S DEATH WAS DEVICE-RELATED. NO ADDITIONAL INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBLATOR II SURGERY SYSTEM ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Death