BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEW METZENBAUM SCISSOR DISPOSABLE

    MDR report key: 6629200 · Received June 9, 2017

    Report

    Report Number
    1223422-2017-00075
    Event Type
    Malfunction
    Date Received
    June 9, 2017
    Date of Event
    April 19, 2017
    Report Date
    April 19, 2017
    Manufacturer
    MICROLINE SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K962119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION IS NOT POSSIBLE BECAUSE THE PRODUCT WAS NOT RETURNED TO MICROLINE SURGICAL. MICROLINE INC., HAS NOTICED AN INCREASE OF REPORTED DEVICES WITH THIS SIMILAR FAILURE. A CORRECTIVE ACTION PLAN HAS BEEN ISSUED IN EFFORTS TO ADDRESS THE INCREASE OF THESE TYPE OF FAILURES REF CAPA (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED, DECONTAMINATED AND VISUALLY INVESTIGATED. UPON VISUAL INSPECTION THIS COMPLAINT HAS BEEN CONFIRMED. THE RETURNED TIPS WERE RETURNED WITH A MISSING HEAT SHRINK MICROLINE INC., HAS NOTICED AN INCREASE OF REPORTED DEVICES WITH THIS SIMILAR FAILURE. A CORRECTIVE ACTION PLAN HAS BEEN ISSUED IN EFFORTS TO ADDRESS THE INCREASE OF THESE TYPE OF FAILURES REF CAPA (B)(4).

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC SURGICAL PROCEDURE, THE HEAT SHRINK FROM THE RENEW METZENBAUM SCISSOR TIP BROKE. ANESTHESIA AND PROCEDURE TIME WAS NOT EXTENDED. NO HARM TO THE PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412490 RENEW METZENBAUM SCISSOR DISPOSABLE MANUAL DETACHABLE SURGICAL INSTRUMENTS GEI MICROLINE SURGICAL, INC. 3112 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1