BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERAMO RONDO TORLOCK NON-TRAUM.MICRO FORCEPS

    MDR report key: 24617402 · Received March 17, 2026

    Report

    Report Number
    3001286223-2026-00001
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    January 7, 2026
    Report Date
    March 17, 2026
    Manufacturer
    FEHLING INSTRUMENTS GMBH
    Product Code
    DWS
    UDI-DI
    04058749121391
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE TEETH OF THE WORKING PART AT THE DISTAL END ARE DAMAGED. THE LAST TOOTH OF THE SINGLE ROW OF TEETH IS BENT DISTALLY AND PARTIALLY TORN AWAY FROM THE BASE MATERIAL. FURTHERMORE, THE SURFACE OF THE TEETH AT THE AFFECTED POINT IS PARTIALLY DEFORMED AND EXPOSED BARE METAL. THE BATCH HISTORY WAS CHECKED AND IT DIDN'T SHOW ANY DEVIATIONS. OUR REPROCESSING INSTRUCTION STATES THE FOLLOWING: VISUALLY INSPECT FOR DAMAGE AND WEAR USING A MAGNIFYING LAMP. PAY PARTICULAR ATTENTION TO CRITICAL POINTS ON MOVING PARTS AND IN THE WORK AREA. DEFECTIVE, DAMAGED INSTRUMENTS WHOSE LABEL IS NO LONGER LEGIBLE MUST BE SORTED OUT AND CLEANED AND DISINFECTED BEFORE BEING RETURNED TO THE MANUFACTURER. RE-PAIRS MAY ONLY BE CARRIED OUT BY THE MANUFACTURER OR WORKSHOPS AUTHORIZED

    Description of Event or Problem · 0

    THIS IS A FINE MICRO-FORCEPS USED IN SURGERY. THE TEETH OF THE WORKING PART AT THE DISTAL END ARE DAMAGED. THE LAST TOOTH OF THE SINGLE ROW OF TEETH IS BENT DISTALLY AND PARTIALLY TORN AWAY FROM THE BASE MATERIAL. FURTHERMORE, THE SURFACE OF THE TEETH AT THE AFFECTED POINT IS PARTIALLY DEFORMED AND EXPOSED BARE METAL. INTRAOPERATIVE FINDING: UPON PALPATION OF THE HEART MUSCLE, A TEAR IN THE TISSUE WITH BLEEDING OCCURRED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676077 CERAMO RONDO TORLOCK NON-TRAUM.MICRO FORCEPS MICRO FORCEPS DWS FEHLING INSTRUMENTS GMBH COD-1T 905643 04058749121391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other