BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECHNO-CUT SURGICAL BLADE

    MDR report key: 13118109 · Received December 29, 2021

    Report

    Report Number
    MW5106362
    Event Type
    Malfunction
    Date Received
    December 29, 2021
    Date of Event
    June 21, 2021
    Report Date
    December 27, 2021
    Manufacturer
    NIRAJ INDUSTRIES PVT. LTD.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    BLADE BROKE IN HALF DURING A ROBOTIC SPINE PROCEDURE. FORTUNATELY THE PIECE WAS RECOVERED AND THERE WAS NO HARM TO THE PT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014001 TECHNO-CUT SURGICAL BLADE BLADE, SCALPEL GES NIRAJ INDUSTRIES PVT. LTD. 0473 1729 10AC

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male