BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDLE CEV1039-5-B DIA 5MM ANG [MXI/XOM]

    MDR report key: 3111429 · Received May 14, 2013

    Report

    Report Number
    1045254-2013-00380
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 17, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. A CEV649-5B TUBE CEV649-5B DIA 5MM 350MM (LOT: 120101). A CEV605-3 SCISSORS INSERT. A CEV605-3 3PK 350MM (LOT: 111102). (B)(4). THE THREE COMPLAINT DEVICES WERE RETURNED AND EVALUATED. THE HANDLE WAS FOUND CRACKED AT THE CONNECTION LEVEL. NO OTHER ISSUES WERE FOUND. THE CRACK WAS MOST LIKELY THE CONSEQUENCE OF THE MULTIPLE USES AND CONSTRAINTS AT THE CONNECTION LEVEL. THE INSTRUMENT SHEATH WAS FOUND DAMAGED WITH TRACES OF IMPACT. HOWEVER, THE ELECTRICAL TESTS CARRIED OUT ON THE INSTRUMENT FOUND THE DEVICE TO CONFORM TO SPECIFICATIONS. THE SHEATH DAMAGE WAS LIKELY THE CONSEQUENCE OF REPEATED REPROCESSING OF THE DEVICE. THE BLADES WERE FOUND TO HAVE TRACES OF IMPACTS AND WERE BLUNT. THE BLADES WERE DAMAGED AND REQUIRE SHARPENING. NONE OF THE DAMAGES HIGHLIGHTED COULD HAVE LED TO REPORTED EVENT. THE MOST LIKELY CAUSE OF THE EVENT WAS A NON-VOLUNTARY CONTACT BETWEEN THE PATIENT BODY AND THE NON-ISOLATED HANDLE DURING COAGULATION. THIS IS ADDRESSED IN THE IFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS BURNED WITH THE HANDLE AT THE LEFT HYPOCHONDRIUM LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213332 HANDLE CEV1039-5-B DIA 5MM ANG [MXI/XOM] ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC XOMED, INC. CEV1039-5-B 10/98

    Patients

    Seq Age Sex Outcome Treatment
    1 Other