BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER-ENDOSCOPY

    MDR report key: 239344 · Received September 8, 1999

    Report

    Report Number
    MW1017121
    Event Type
    Malfunction
    Date Received
    September 8, 1999
    Date of Event
    August 11, 1999
    Report Date
    August 31, 1999
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 2.5 MM MICRODEBRIDER BLADE BROKE OFF WHILE SHAVER INSIDE RT ANKLE. X-RAY TAKEN. REMOVED THROUGH PORTAL WITH SMALL GRASPERS. NO INJURY TO PT, BUT PROLONGED OR TIME TO REMOVE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER-ENDOSCOPY MICRODEBRIDER BLADE HRX STRYKER ENDOSCOPY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other