BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOOK SCISSORS Ø 3.4MM

    MDR report key: 17406295 · Received July 27, 2023

    Report

    Report Number
    9611102-2023-00050
    Event Type
    Injury
    Date Received
    July 27, 2023
    Date of Event
    June 22, 2023
    Report Date
    July 27, 2023
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    HRR
    UDI-DI
    04055207017760
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INSTRUMENT HAS NOT YET BEEN SENT FOR EXAMINATION BY THE USER. AS SOON AS THE INSTRUMENT IS IN HOUSE, THE EXAMINATION WILL BE STARTED. SO FAR, THERE HAS BEEN NO COMPARABLE CASE OF THIS TYPE.

    Description of Event or Problem · 0

    THE USER FACILITY HAS INFORMED RICHARD WOLF GMBH OF AN ISSUE REGARDING A HOOK SCISSORS Ø 3.4MM, PART ID: 8488041, LOT # UNKNOWN. ACCORDING TO THE RECEIVED INFORMATION FROM THE CUSTOMER, LE DR RUH, "REPORT INTRAOPERATIVE BREAKAGE OF A PAIR OF ARTHROSCOPIC SCISSORS WITH LOSS OF PART OF THE INSTRUMENT IN THE JOINT." THE REPORTER CLAIMED THAT THE PRESENCE OF THE METALLIC ELEMENT IN THE JOINT IS A CONTRAINDICATION FOR AN MR/EXAMINATION. THEREFORE, THE POSSIBILITY OF RECOVERING THE EXOGENOUS ELEMENT IS IMPOSSIBLE. THE PATIENT OUTCOME IS NEGATIVE AND THE LONG TERM CONSEQUENCES IS UNKNOWN. THIS CASE WAS REPORTED BY THE CUSTOMER TO THE FRENCH NATIONAL AGENCY FOR THE SAFETY OF MEDICINES AND HEALTH PRODUCTS (ANSM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663584 HOOK SCISSORS Ø 3.4MM HRR RICHARD WOLF GMBH 8488041 UNKNOWN 04055207017760

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other