BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEW MINI ENDOCUT SCISSOR TIP, DISPOSABLE

    MDR report key: 12542613 · Received September 28, 2021

    Report

    Report Number
    1223422-2021-00007
    Event Type
    Malfunction
    Date Received
    September 28, 2021
    Date of Event
    September 13, 2021
    Report Date
    September 28, 2021
    Manufacturer
    MICROLINE SURGICAL INC.
    Product Code
    GEI
    UDI-DI
    00811099010012
    PMA / PMN Number
    K962119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DECONTAMINATED AND FORWARDED TO QUALITY ENGINEERING FOR EVALUATION THE SCISSOR AND THE DETACHED SHRINK TUBING WERE RETURNED FOR EXAMINATION THE SCISSOR ASSEMBLY WAS MISSING THE SHRINK TUBING. THE SCISSOR HAS NO VISUAL DAMAGE EXCEPT FOR THE SHRINK TUBE THAT WAS NOT ATTACHED. THE SCISSORS WERE TESTED USING A KNOWN GOOD HAND PIECE. THE SCISSOR FUNCTIONED CORRECTLY. THE SHRINK TUBE WAS DAMAGED A SPLIT (LENGTH WISE). THE DISTAL EDGE OF THE SHRINK TUBE SHOWS SIGNS OF BEING ROLLED AND CUT. THIS APPEARANCE OF THE DAMAGE INDICATES THAT THE SHRINK TUBE WAS CUT BY IMPACT WITH A RIGID OBJECT

    Description of Event or Problem · 1

    DURING A PROCEDURE, OUR CUSTOMER FOUND THAT THE PART WHICH SHOULD BE ADHERED CAME OFF. THE SURGEON IMMEDIATELY PICKED IT UP THUS THERE WAS NEITHER HEALTH DAMAGE NOR EXTENSION OF THE PROCEDURE. A SPARE INSTRUMENT WAS USED TO CONTINUE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439832 RENEW MINI ENDOCUT SCISSOR TIP, DISPOSABLE MANUAL DETACHABLE SURGICAL INSTRUMENTS GEI MICROLINE SURGICAL INC. 3152 00157004 00811099010012

    Patients

    Seq Age Sex Outcome Treatment
    1