BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEW IV HANDPIECE 42CM

    MDR report key: 8759602 · Received July 2, 2019

    Report

    Report Number
    MW5087831
    Event Type
    Malfunction
    Date Received
    July 2, 2019
    Manufacturer
    MICROLINE SURGICAL, INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MICROLINE SURGICAL INC., MARLOW SCISSOR HANDPIECE, WAS NOTED TO HAVE COMPROMISED INTERNAL (WHITE) INSULATION BY THE THREADS AT THE END OF THE HANDPIECE. THIS WAS DISCOVERED DURING SETUP, PRIOR TO CURRENT PATIENT USE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545938 RENEW IV HANDPIECE 42CM ELECTROSURGICAL, CUTTING AND COAGULATION AND ACCESSORIES GEI MICROLINE SURGICAL, INC 0086 GTIN 00811099010791

    Patients

    Seq Age Sex Outcome Treatment
    1