BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRCULAR CUTTING PUNCHES

    MDR report key: 10689779 · Received October 16, 2020

    Report

    Report Number
    10689779
    Event Type
    Malfunction
    Date Received
    October 16, 2020
    Date of Event
    February 27, 2020
    Report Date
    September 9, 2020
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    KTF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

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 THIS WAS NOTICED WHEN THE INSTRUMENT WAS WITHDRAWN FROM THE PATIENT.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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157732 CIRCULAR CUTTING PUNCHES PUNCH, ENT KTF OLYMPUS WINTER & IBE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 12410 DA