BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MISEAL DISPOSABLE KIT

    MDR report key: 2152745 · Received June 24, 2011

    Report

    Report Number
    2954339-2011-00014
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 23, 2011
    Manufacturer
    STARION INSTRUMENTS
    Product Code
    GEI
    PMA / PMN Number
    K062257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE MISEAL DISPOSABLE TIP WAS RETURNED, DECONTAMINATED AND INVESTIGATED. NO MISEAL HANDPIECE OR DISPOSABLE CABLE WAS RETURNED, THEREFORE NO INVESTIGATION COULD BE DONE ON THE HANDPIECE OR CABLE. THE RETURNED TIP WAS FOUND TO HAVE NO COSMETIC ABNORMALITIES. A CLOSER INSPECTION OF THE TIP SHOWED THAT THE RIGHT JAW TIP BOOT WAS TORN DISTALLY AND THE BOOT TIP WAS MISSING, CONFIRMING THE COMPLAINT. A SUBSTANTIAL AMOUNT OF CHARRED TISSUE WAS ADHERED TO THE JAWS, LINKS AND THE AREA BETWEEN THE JAWS. IT IS NOT CLEAR IF THIS CONDITION CONTRIBUTED TO THE TEARING OF THE SILICONE BOOT. IT APPEARS THAT THE BOOT WAS CUT OR TORN ON THE OUTSIDE SURFACE OF THE JAW AND THE TEAR PROGRESSED TO THE INSIDE OF THE JAW. THE TORN BOOT MAY HAVE OCCURRED UPON REMOVAL OF THE IMPLANTED SURGICAL MESH, OR THE BOOT MAY HAVE BEEN DAMAGED EARLIER IN THE PROCEDURE POSSIBLY DURING INSERTION OR WITHDRAWAL OF THE DEVICE FROM THE CANNULA. A SHARP EDGE INSIDE OF THE CANNULA CAN CAUSE A CUT IN THE SILICONE BOOT WITH EXTENDED USE, WHICH CAN TURN INTO A TEAR RESULTING IN A PIECE OF THE BOOT TEARING FREE.

    Description of Event or Problem · 1

    THE SURGEON WAS REVISING A PREVIOUS NISSEN FUNDOPLICATION AND HIATAL HERNIA REPAIR. THERE WAS SIGNIFICANT SCAR TISSUE. THE DEVICE WAS USED EXTENSIVELY AND PERFORMED WELL UNTIL DURING THE COURSE OF REMOVING ADHESIONS IN THE VICINITY OF THE PREVIOUS HERNIA, THE SURGEON ALSO CAUGHT A PIECE OF THE SURGICAL MESH USED IN THE ORIGINAL REPAIR. THE SURGEON DID NOT NOTICE THAT THE MESH WAS IN THE HAWS OF THE DEVICE UNTIL THE SILICON BOOT ON THE DISTAL TIP OF THE DEVICE BEGAN TO SEPARATE. AT THIS POINT HE STOPPED USING THE DEVICE. NO PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MISEAL DISPOSABLE KIT MISEAL DISPOSABLE TIP AND CABLE GEI STARION INSTRUMENTS 452-131D 103013

    Patients

    Seq Age Sex Outcome Treatment
    1