BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRCULAR CUTTING PUNCHES

    MDR report key: 10947909 · Received December 4, 2020

    Report

    Report Number
    3010726901-2020-00001
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Report Date
    December 3, 2020
    Manufacturer
    EVONOS GMBH & CO. KG
    Product Code
    KTF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PER MR (B)(4), AN ADULT MALE UNDERWENT ENT SURGERY. WHILE USING A MUSHROOM PUNCH TO WIDEN THE SPHENOID. OSTIUM THE HEAD OF THE MUSHROOM ESSENTIALLY FELL OF THE INSTRUMENT AND INTO THE LEFT SPHENOID SINUS. THIS WAS NOTICED WHEN THE INSTRUMENT WAS WITHDRAW FROM THE PATIENT. THE DISTAL END OF THE INSTRUMENT WAS THEN IDENTIFIED IN THE LEFT SPHENOID SINUS AND WAS SUCCESSFULLY REMOVED WITH THE STRAIGHT SUCTION. THE LEFT SPHENOID SINUS WAS THEN INSPECTED AGAIN AND WAS FOUND TO BE EMPTY. THIS INSTRUMENT WAS THEN MARKED AND PASSED OF THE FIELD FOR DISCUSSION WITH THE MANUFACTURE. THE SURGEON SPENT APPROXIMATELY 10MIN LOOKING FOR AND RETRIEVING THE MISSING PIECE OF THE PUNCH FROM THE SURGICAL SITE, PROLONGING THE PROCEDURE. THERE WSA NO IDENTIFIED HARM TO THE PATIENT. THE PATIENT DISCHARGED HOME LATER THAT SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1414977 CIRCULAR CUTTING PUNCHES PUNCH, ENT KTF EVONOS GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR