BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUNG CARB RASP 3 & 4

    MDR report key: 19408759 · Received May 28, 2024

    Report

    Report Number
    0001920664-2024-00078
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Date of Event
    April 17, 2024
    Report Date
    May 6, 2024
    Manufacturer
    BAUSCH + LOMB
    Product Code
    KBA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE RASP HAS A TUNGSTEN-CARBIDE INSERT WHICH IS INSERTED INTO THE STEEL. THE INSTRUMENT WAS RECEIVED WITH PART OF THE TUNGSTEN-CARBIDE INSERT MISSING DUE TO EXCESSIVE MECHANICAL FORCE. THERE WAS NO ASSIGNABLE CAUSE TO THE COMPLAINT. THE TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO CORRECTIVE ACTION REQUIRED.

    Description of Event or Problem · 0

    THE USER FACILITY IN CANADA REPORTED THE SURGEON VERIFIED THE RESIDENT'S WORK WITH A RASP ON THE PATIENT'S NOSE, AND NOTICED A PIECE OF THE RASP MISSING FROM THE INSTRUMENT ONCE REMOVED FROM THE PATIENT. IT WAS FOUND IN THE PATIENT. AN X-RAY CONFIRMED THAT NO SMALLER FRAGMENTS HAD BEEN RETAINED. IT APPEARS THAT ALL FRAGMENTS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399076 TUNG CARB RASP 3 & 4 HANDHELD SURGICAL INSTRUMENT KBA BAUSCH + LOMB P1000 4

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown