BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISPOSABLE MINI ENDOCUT SCISSORS TIP

    MDR report key: 1943731 · Received December 16, 2010

    Report

    Report Number
    1223422-2010-00006
    Event Type
    Other
    Date Received
    December 16, 2010
    Date of Event
    October 27, 2010
    Report Date
    December 17, 2010
    Manufacturer
    MICROLINE SURGICAL INN
    Product Code
    KNS
    PMA / PMN Number
    K962119
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCISSORS TIPS IN QUESTION WERE NOT RETURNED; THEREFORE, NO INVESTIGATION COULD BE CONDUCTED. A DVD OF THE TIP USED DURING SURGERY WAS RETURNED AND VIEWED. THE RETURNED DVD SHOWED A (B)(4) DISPOSABLE MINI ENDOCUT SCISSORS TIP BEING USED IN SURGERY. THE USER WAS ROTATING THE HANDPIECE ALONG THE DISTAL PART OF THE INSULATION TO CAUTERIZE, RATHER THAN USING THE METALLIC SURFACE OF THE SCISSORS. THIS RESULTED IN THE HEAT SHRINK TUBING MELTING AND EXPOSING THE CRIMP PIN. THE ELECTRICAL CURRENT FLOWED THROUGH THE SCISSORS TIP AND IT CAME OUT OF THE FRONT HUB MELTING THE HEAT SHRINK TUBING. THE RENEW HANDPIECE WITH THE (B)(4) SCISSORS WERE CLEARLY BEING USED INCORRECTLY, THUS CAUSING THE INSULATION DAMAGE OF THE TIP. THREE STERILE, UNOPENED TIP POUCHES WERE RETURNED FOR ADD'L LOT NUMBER 00103881 FOR (B)(4) DISPOSABLE MINI ENDOCUT SCISSORS TIPS. THREE TIPS FOR EACH LOT 00102923 AND 00103881 WERE MECHANICALLY AND ELECTRICALLY TESTED. THEY PASSED SPECIFICATIONS AND TESTING. NO ISSUES WERE FOUND WITH EITHER DEVICE HISTORY RECORD.

    Description of Event or Problem · 1

    BURN TO THE PATIENT'S OVARY CAUSED BY ARC FROM END OF SCISSORS TIP WHILE USING DIATHERMY ON 50/50 SETTING. THE END THE SCISSORS TIP APPEARS TO HAVE MELTED CAUSING DAMAGE TO THE TIP AND EXPOSING AN INCREASED AMOUNT OF THE SCISSORS TIP END. A DVD WAS PROVIDED SHOWING BURNING TO A CYST THAT WAS BEING REMOVED FROM THE PT. THE BURNING APPEARS AT THE POINT OF THE TIP WHERE THE INSULATION MEETS THE BLADE. AFTER ONLY A FEW SECONDS OF DIATHERMY ON A NEW TIP DAMAGE TO THE END OF THE TIP, EXPOSING THE BLADE (THE INSULATION APPEARS TO HAVE MELTED AWAY). NO ADDITIONAL PT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE MINI ENDOCUT SCISSORS TIP MINI SCISSORS TIP KNS MICROLINE SURGICAL INN 3152 00102923

    Patients

    Seq Age Sex Outcome Treatment
    1