BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGATING DEVICE

    MDR report key: 3060737 · Received March 29, 2013

    Report

    Report Number
    8010047-2013-00083
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FHN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE INSERTION PORTION WAS CUT NEAR THE HANDLE PORTION IN THE CONDITION WHERE THE HOOK OF THE SUBJECT DEVICE WAS RETRACTED WITHIN THE TUBE SHEATH. THERE WERE SEVERAL DEFORMATION IN THE TUBE SHEATH AND THE TUBE SHEATH WAS STRETCHED 9 MM IN THE LENGTH BY THE EXCESSIVE TENSION FORCE. OMSC REVIEWED THE MANUFACTURING RECORDS OF THE SUBJECT DEVICE AND CONFIRMED THAT THERE WAS NO IRREGULARITY. THE HX-20U-1 INSTRUCTION MANUAL ALREADY STATES; WARNINGS: DO NOT REMOVE THE LOOP FROM THE HOOK WHILE THE COIL SHEATH IS NOT EXTENDED FROM THE TUBE SHEATH. OTHERWISE, THE LOOP MAY BE TANGLED WITH THE HOOK AND BECOME IMPOSSIBLE TO BE REMOVED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING A COLONOSCOPY POLYPECTOMY PROCEDURE, THE USER SUCCESSFULLY PLACED THE LOOP OVER A POLYP AND TIGHTENED IT USING THE SUBJECT DEVICE; HOWEVER COULD NOT RELEASE THE LOOP FROM THE SUBJECT DEVICE. THE FACILITY REPORTEDLY CUT THE HANDLE OF THE SUBJECT DEVICE AND WITHDREW THE COLONOSCOPE WHILE THE LOOP AND INSERTION TUBE OF THE DEVICE REMAINED IN THE PATIENT. THEN, THE FACILITY REPORTEDLY MOVED THE LOOP STOPPER TO LIGATE THE POLYP USING AN UNCERTAIN GRASPING FORCEPS. IT WAS REPORTED THAT THE POLYP WAS SUCCESSFULLY LIGATED WITH THE LOOP AND THE INSERTION PORTION OF THE DEVICE WAS WITHDRAWN FROM THE PATIENT. THE FACILITY REPORTEDLY COMPLETED THE PROCEDURE USING SUBJECT DEVICE AND THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131118 LIGATING DEVICE LIGATING DEVICE (POLY LOOP) FHN OLYMPUS MEDICAL SYSTEMS CORPORATION HX-20U-1 K9420

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK