BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AESCULAP ANGULAR HANDPIECE

    MDR report key: 171717 · Received June 2, 1998

    Report

    Report Number
    171717
    Event Type
    Injury
    Date Received
    June 2, 1998
    Date of Event
    March 23, 1998
    Report Date
    June 2, 1998
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    HWE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS USING AESCULAP HANDPIECE (GD456R) WITH A DEPUY, INC. OVAL BURR (CAT. NO. 5607-69) DURING A MICRODISECTOMY WHEN THE BURR DISLODGED FROM THE HANDPIECE CAUSING A DURA TEAR. PHYSICIAN REPAIRED THE DURA TEAR BY CONVERTING CASE FROM MICRODISECTOMY TO LAMINECTOMY. ACCORDING TO THE RISK MANAGER AT FACILITY, IT IS BELIEVED THE SURGEON APPLIED EXCESSIVE PRESSURE WHILE USING THE HANDPIECE THUS CAUSING THE BURR TO BECOME DISLODGED. THE HANDPIECE WAS NOT RETURNED TO AESCULAP FOR EVALUATION; IT CONTINUES TO BE USED BY FACILITY WITHOUT INCIDENT. THIS EVENT TYPE IS OCCURRING BELOW THE FREQUENCY AND SEVERITY THAT ARE USUAL FOR THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AESCULAP ANGULAR HANDPIECE DRILL HANDPIECE HWE AESCULAP AG & CO. KG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention