BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER ENDOSCOPY

    MDR report key: 109783 · Received July 3, 1997

    Report

    Report Number
    109783
    Event Type
    Injury
    Date Received
    July 3, 1997
    Date of Event
    April 21, 1997
    Report Date
    May 8, 1997
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING RIGHT KNEE ARTHROSCOPY, SHAVE AND DEBRIDEMENT, A SLIVER OF METAL CAME OFF THE 3.5 FULL RADIUS SHAVER BEING USED. THE AREA WAS BEING IRRIGATED AND ASPIRATED THROUGHOUT THE PROCEDURE WITH LR AND IT WAS FELT THAT THE SLIVER WAS SUCTIONED OUT. X-RAYS WERE TAKEN AND NO METAL REMNANTS WERE SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER ENDOSCOPY SHAVER HRX STRYKER ENDOSCOPY UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention