BEUDAMED
    FDA Adverse Event Summary report: N

    LARYNGOSCOPE HANDLE

    MDR report key: 11328 · Received February 1, 1994

    Report

    Report Number
    MW4000123
    Date Received
    February 1, 1994
    Report Date
    September 11, 1992
    Manufacturer
    AESCULAP INSTRUMENT CORP.
    Product Code
    EQN
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LARYNGOSCOPE HANDLES MFG WITH A SCREW THREAD CROSS BAR/PIN ARE SUBJECT TO THE PIN LOOSENING AND FALLING OUT. DURING A RECENT AMBULANCE TRANSFER, AN ER PHYSICIAN WAS READYING A LARYNGOSCOPE FOR POSSIBLE USE ON A PEDIATRIC OVERDOSE PT. THE HANDLE WAS READILY LOCATED, BUT THE SCREW THREADED CROSS BAR/PIN HAD BECOME UNSCREWED AND FELL OUT OF THE HANDLE. IT WAS LOCATED AFTER A SHORT SEARCH, BUT THIS WAS PURELY LUCK AS THE PIECE IS SO SMALL IT MIGHT HAVE BEEN LOST COMPLETELY. THIS WOULD HAVE RENDERED THE HANDLE INOPERABLE. RECOMMENDATION: RECOMMEND THESE TYPE HANDLES WITH SCREW THREADED CROSS BAR/PINS BE REMOVED FROM AMBULANCE, FIELD AND CLINIC USE. ANESTHESIA DEPTS COULD CONTINUE USING THESE BECAUSE SUCH EQUIPMENT IS SUBJECT TO RIGOROUS AND REGULAR FUNCTION CHECKS. ALSO, ANESTHESIA DEPTS WOULD BE THE MOST LIKELY TO HAVE ADD'L BACK UP HANDLES SHOULD ONE OF THESE THREAD TYPES FAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARYNGOSCOPE HANDLE EQN AESCULAP INSTRUMENT CORP. 319

    Patients

    Seq Age Sex Outcome Treatment
    1 *