BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYONICS (GERMANY STAINLESS)

    MDR report key: 117563 · Received August 26, 1997

    Report

    Report Number
    117563
    Event Type
    Injury
    Date Received
    August 26, 1997
    Date of Event
    February 10, 1997
    Report Date
    March 5, 1997
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY INC.
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING LEFT KNEE ARTHROSCOPY, THE GRASPER JAW BROKE OFF IN THE PTS KNEE. X-RAYS TAKEN AND THEN C-ARM WAS PERFORMED TO RETRIEVE INSTRUMENT (TOOK OVER 2 HRS.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYONICS (GERMANY STAINLESS) GRASPER JAW - BASKET FORCEP HRX SMITH & NEPHEW ENDOSCOPY INC. 3253 *

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention