BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALM

    MDR report key: 286374 · Received July 19, 2000

    Report

    Report Number
    2027060-2000-00006
    Event Type
    Other
    Date Received
    July 19, 2000
    Date of Event
    June 22, 2000
    Report Date
    July 6, 2000
    Manufacturer
    ALMSE
    Product Code
    FSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT A 3 1/2 YEAR OLD STERILIZABLE HANDLE CAME APART WHILE IN USE AND FELL INTO THE SURGICAL SITE. THE STERILIZABLE HANDLES ARE DESIGNED AS A DISPOSABLE ITEM, AND ARE GUARANTEED FOR A MINIMUM OF 20 STERILIZATION CYCLES. THE CUSTOMER HAS REPORTED THAT THEY ARE EVALUATING THEIR PROCESS FOR REPLACEMENT OF USED HANDLES. ALM PROJECT SPECIALIST WILL CONDUCT PHYSICAL EVAL OF THEIR EXISTING INVENTORY AND PROVIDE IN-SERVICING INSTRUCTIONS FOLLOWING THEIR PROCESS REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALM STERILIZABLE HANDLE FSY ALMSE 300049 FEB. 1997

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other