BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEW ENDOCUT SCISSOR TIP, DISPOSABLE.

    MDR report key: 6341782 · Received February 17, 2017

    Report

    Report Number
    1223422-2017-00016
    Event Type
    Malfunction
    Date Received
    February 17, 2017
    Date of Event
    January 17, 2017
    Report Date
    February 17, 2017
    Manufacturer
    MICROLINE SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K962119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS CLEANED AND STERILIZED ACCORDING TO THE MICROLINE SURGICAL, INC., INTERNAL PROCEDURE. A VISUAL INSPECTION WAS CONDUCTED ON THE SCISSOR TIP. THERE WAS NO SIGNS OF PHYSICAL DAMAGE OR DEFORMATION TO THE SCISSOR TIP. THE RETURNED SCISSOR WAS ATTACHED TO A WORKING HANDPIECE, TO PERFORM A CUT TEST. THE SCISSOR TIP WAS NOT FUNCTIONAL AS INTENDED. TO DETERMINE IF THERE WAS AN ISSUE WITH THE COMPONENTS ADDITIONAL EVALUATION WAS NEEDED. GEOMETRIC MEASUREMENTS OF THE INTERNAL COMPONENTS; DISK SPRING, FRONT HUB, AND CRIMP PIN SHOW THAT THERE IS INSUFFICIENT FORCE PRESENT WITHIN THE INTERNAL COMPONENTS OF THE SCISSOR TIP. LACK OF THIS FORCE WOULD CAUSE THE DEVICE TO NOT WORK AS DESIGNED. THE ROOT CAUSE TO THE SCISSOR TIP NOT CUTTING IS ATTRIBUTED TO INSUFFICIENT COMPRESSIVE FORCE APPLIED TO THE ASSEMBLY.

    Description of Event or Problem · 1

    THE RENEW ENDOCUT SCISSOR DID NOT CUT DURING A SURGICAL PROCEDURE. THE PROCEDURE AND ANESTHESIA TIME WAS NOT EXTENDED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123429 RENEW ENDOCUT SCISSOR TIP, DISPOSABLE. MANUAL DETACHABLE SURGICAL INSTRUMENT. GEI MICROLINE SURGICAL, INC. 3142 00129482

    Patients

    Seq Age Sex Outcome Treatment
    1 Other