BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS REUSABLE LOOP CUTTER

    MDR report key: 1813431 · Received August 19, 2010

    Report

    Report Number
    8010047-2010-00164
    Event Type
    Malfunction
    Date Received
    August 19, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 22, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    OFF LABEL USE. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE DEVICE WAS RECEIVED IN A CONTAMINATED STATE, WHICH LIMITED THE EVAL TO VISUAL INSPECTION. THE EVAL REVEALED THAT THE WORKING LENGTH COIL SHEATH WAS BROKEN AND SEPARATED APPROX 75 MM FROM THE HANDLE. THE DISTAL END OF THE DEVICE WAS EXAMINED AND NO SIGNS OF DAMAGE OR FOREIGN OBJECTS WERE OBSERVED THAT WOULD IMPEDE OPERATION OF THE CUTTING JAW. BASED ON THE INFO PROVIDED, THE CAUSE OF THE REPORTED PHENOMENON WAS APPEARS TO BE DUE TO USER ERROR, AS THE LOOP CUTTER IS NOT INTENDED TO CUT SUTURES. THE FS-5U-1 INSTRUCTION MANUAL STATES IN THE INTENDED USE SECTION: "THIS INSTRUMENT IS USED TO CUT THE RESIDUAL END OF THE OLYMPUS LOOP USED FOR LIGATING TISSUE WITHIN THE DIGESTIVE TRACT. DO NOT USE THIS INSTRUMENT FOR ANY OTHER PURPOSE." THE FS-5U-1 INSTRUCTION MANUAL ALSO STATES: WARNING: DO NOT USE THE INSTRUMENT TO CUT ANY OBJECTS OTHER THAN THE SURPLUS OF OLYMPUS LOOP (E.G., MAJ-254, MAJ-340). IF ANYTHING OTHER THAN THE SURPLUS OF THE LOOP IS CUT, THE BLADES MAY BE DAMAGED AND UNABLE TO PERFORM PROPERLY, THE CUT OBJECT MAY BE CAUGHT IN THE TIP OF THE INSTRUMENT, AND IT MAY BECOME DIFFICULT TO SAFELY REMOVE THE INSTRUMENT FROM THE BODY. SUCH OBJECTS OTHER THAN THE SURPLUS OF LOOP MAY INCLUDE, STENT WIRE, SEWING TREADS, AND LOOP STOPPERS. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A MEDWATCH REPORT, WHICH STATED: "THE OLYMPUS ENDO THERAPY LOOP CUTTER WAS INSERTED THROUGH THE PENTAX SCOPE CHANNEL DURING AN ESOPHAGOGASTRODUODENOSCOPY DIAGNOSTIC PROCEDURE. THE CUTTER WAS TESTED PRIOR TO INSERTION BY OPENING AND CLOSING THE DEVICE. IT FUNCTIONED AS EXPECTED. THE LOOP CUTTER WAS INTRODUCED THROUGH THE CHANNEL OF THE SCOPE, CLOSED ON THE SUTURE AND THE DOCTOR WAS UNABLE TO REOPEN THE LOOP CUTTER TO RELEASE. ANOTHER SURGEON WHO WAS IN THE DEPARTMENT, ASSISTED BY BURNING THE SUTURE, TO RELEASE THE DEVICE BY USING THE ARGON CAUTERY. THE PT TOLERATED THE PROCEDURE WELL AND WENT ONTO RECOVERY. THE DOCTOR CONVEYED THAT THIS WAS A DEVICE MALFUNCTION OR USE ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS REUSABLE LOOP CUTTER LOOP CUTTER KOG OLYMPUS MEDICAL SYSTEMS CORPORATION FS-5U-1 K5XD-1501

    Patients

    Seq Age Sex Outcome Treatment
    1 DURING THE PROCEDURE.| ARGON CAUTERY DEVICE WAS SAID TO HAVE BEEN USED| PENTAX SCOPE MODEL AND SERIAL NUMBER UNK