BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER ENDOSCOPY

    MDR report key: 381285 · Received March 7, 2002

    Report

    Report Number
    MW1024308
    Event Type
    Malfunction
    Date Received
    March 7, 2002
    Date of Event
    February 14, 2002
    Report Date
    February 20, 2002
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DRILL USED DURING MANDIBLE SURGERY OVERHEATED CAUSING A BURN TO PT'S LOWER LIP. LIP REQUIRED SUTURES. PT WAS DISCHARGED IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER ENDOSCOPY ARTHROPLASTY MOTOR DRIVE HRX STRYKER ENDOSCOPY 5100-1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other