BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOOP CUTTER

    MDR report key: 3032142 · Received March 6, 2013

    Report

    Report Number
    8010047-2013-00043
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OMSC FOLLOWED UP WITH THE USER FACILITY TO OBTAIN MORE DETAILED INFO. IT WAS REPORTED THAT THE FACILITY TRIED TO CUT THE TWO FILAMENTS OF THE EXCESSIVE PORTION OF THE LOOP TOGETHER AND THE ONE FILAMENT STUCK IN THE TIP OF THE SUBJECT DEVICE. THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVAL. THE EVAL CONFIRMED THAT THE FILAMENT OF THE LOOP STUCK IN THE TIP OF THE SUBJECT DEVICE, HOWEVER, THERE WERE NO OTHER ABNORMALITIES RELATED TO THE PHENOMENON IN THE SUBJECT DEVICE. THE FS-5Q-1 INSTRUCTION MANUAL ALREADY STATES; WARNINGS: DO NOT TRY TO CUT THE LOOP THAT IS NOT POSITIONED ON BOTH EDGES OF THE LOOP HANGER AS PLUMB AS POSSIBLE FOR THE BLADE. IT MAY MAKE CUTTING CAUGHT IN THE DISTAL END OF THE INSTRUCTION, WHICH COULD MAKE IT DIFFICULT OR IMPOSSIBLE TO REMOVE FROM THE PT. IN THIS CASE, USE PLIERS TO CUT THE INSERTION PORTION OF THE INSTRUMENT WHERE IT EXTENDS FROM THE BIOPSY VALVE OF THE ENDOSCOPE. REMOVE THE ENDOSCOPE FROM THE BODY, THEN REINSERT THE ENDOSCOPE AND CUT THE LOOP WITH A SPARE LOOP CUTTER.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS (OMSC) WAS INFORMED THAT DURING THERAPEUTIC COLONOSCOPY POLYPECTOMY PROCEDURE, A LOOP WAS TIGHTENED AROUND A POLYP AS A PREVENTIVE MEASURE FOR HEMOSTASIS. THE USER REPORTEDLY ATTEMPTED TO CUT AN EXCESSIVE PORTION OF THE LOOP, HOWEVER, THE LOOP WAS SAID TO HAVE BECOME STUCK IN THE TIP OF THE SUBJECT DEVICE FROM THE PT AND COULD NOT BE RELEASED. IT WAS REPORTED THAT THE FACILITY COULD RELEASE THE LOOP AND WITHDRAW THE SUBJECT DEVICE SINCE THE EXCESSIVE PORTION OF THE LOOP TORN AFTER THEY TRIED TO WITHDRAW THE SUBJECT DEVICE. THE PROCEDURE WAS REPORTEDLY COMPLETED W/O AN ADD'L DEVICE. THERE WAS NO REPORT OF PT INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96607 LOOP CUTTER LOOP CUTTER KOG OLYMPUS MEDICAL SYSTEMS CORPORATION FS-5Q-1 K6802

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK