BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURETTE

    MDR report key: 16831790 · Received April 27, 2023

    Report

    Report Number
    MW5117081
    Event Type
    Malfunction
    Date Received
    April 27, 2023
    Date of Event
    April 20, 2023
    Report Date
    April 20, 2023
    Manufacturer
    BOSS INSTRUMENTS, LTD
    Product Code
    FZS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING SURGERY, 2 DIFFERENT SURGICAL INSTRUMENT BOSS ''NEW TRAY OF INSTRUMENTS GOTTEN X3'' NEWLY PURCHASED SETS. WHILE PERFORMING 15 LAMINECTOMY TURBO DECOMPRESSION CASE THE SURGEON WAS " LEISUING BONE IT CLOSED MADE A BIG CLICK SOUND AND DID NOT OPERATE PROPERLY. NEW SET "# 3 TO ROOM" USING CURETTE IT TOTALLY BENT INSIDE. NO HARM TO PATIENT. REFERENCE REPORT: MW5117080.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817999 CURETTE CURETTE, SURGICAL, GENERAL USE FZS BOSS INSTRUMENTS, LTD 70-7122

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male