BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAUTERY FORCEPS

    MDR report key: 2102978 · Received May 13, 2011

    Report

    Report Number
    2954339-2011-00013
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Report Date
    May 12, 2011
    Manufacturer
    STARION INSTRUMENTS
    Product Code
    HQR
    PMA / PMN Number
    K050308
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE CAUTERY FORCEPS WAS RETURNED, DECONTAMINATED AND INVESTIGATED. A VISUAL INSPECTION FOUND A DISTAL TEAR LOCATED ON THE TOOTHED SIDE OF THE BOOT. THIS BOOT WAS SPLIT, NOT "MELTED" AND NO MATERIAL WAS MISSING. A CLOSER INSPECTION OF THE BOOT TEAR REVEALED THAT THE THICKNESS OF THE TIP BOOT APPEARED THIN. IF THE DEVICE IS ACTIVATED W/O TISSUE BEING PRESENT WITH THE JAWS, THE TIP BOOT WALL IS PRE-STRESSED BY OVER STRETCHING, CAUSING THE BOOT TO SPLIT. THE COMBINATION OF THE THINNER BOOT AND AN OVER STRESSED BOOT MAY HAVE HELPED DEVELOP THE BOOT SPLIT WHEN THE DEVICE WAS ACTIVATED. A REVIEW OF THE SAME POSSIBLE BOOT CONFIGURATION FOUND THAT THIS IS AN ISOLATED INCIDENT. THE RETURNED DEVICE WAS ELECTRICALLY INSPECTED AND MEETS STANDARDS. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO ISSUES. COMPLAINTS OF THE DEVICES BUILT WITH THE SAME BOOT LOT NUMBER WERE REVIEWED FOR ANY SIMILAR INSTANCES TO DETERMINE THE FREQUENCY OF THE ISSUE. THIS SITUATION WILL BE MONITORED.

    Description of Event or Problem · 1

    THIS WAS ORIGINALLY REPORTED AS THE ENDS MELTED. DURING THE INVESTIGATION IT WAS DETERMINED THAT THE BOOT WAS SPLIT. NO PT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAUTERY FORCEPS CAUTERY FORCEPS HQR STARION INSTRUMENTS 100-004D 006003

    Patients

    Seq Age Sex Outcome Treatment
    1