BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOOP CUTTER

    MDR report key: 5187062 · Received October 29, 2015

    Report

    Report Number
    8010047-2015-01049
    Event Type
    Malfunction
    Date Received
    October 29, 2015
    Date of Event
    October 14, 2015
    Report Date
    October 14, 2015
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    JYA
    PMA / PMN Number
    K955065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSERTION PORTION OF THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THAT THE HANDLE WAS SEVERED. THE LOOP WAS CAUGHT BY THE CUTTER AND THE LOOP HANGER, AND WAS CRUSHED. OMSC MEASURED THE DIMENSIONS OF THE CUTTER AND THE LOOP HUNGER. AS A RESULT, THEY SATISFY THE PRODUCT STANDARDS. AS THE RESULT OF CHECKING THE MANUFACTURING RECORD OF THE SAME LOT, THERE WAS NOTHING ABNORMAL DETECTED. BASED ON THE INVESTIGATION OF THE SUBJECT DEVICE, OMSC CONCLUDED THAT THE LOOP WAS CAUGHT IN THE LOOP CUTTER, BECAUSE THE DOCTOR PULLED THE SLIDER WITHOUT POSITIONING THE LOOP VERTICALLY TO THE LOOP HUNGER. THE INSTRUCTION MANUAL OF THE SUBJECT DEVICE WARNS; 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 THE LOOP IMPOSSIBLE, OR RESULT IN THE LOOP GETTING CAUGHT IN THE DISTAL END OF THE INSTRUMENT, WHICH COULD MAKE IT DIFFICULT OR IMPOSSIBLE TO REMOVE FROM THE PATIENT. 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. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    IT WAS INFORMED THAT THE DOCTOR ATTEMPTED TO CUT THE LOOP WITH THE SUBJECT DEVICE DURING A COLORECTAL POLYPECTOMY. THEN THE LOOP STUCK IN THE SUBJECT DEVICE, AND THE SUBJECT DEVICE COULD NOT COME OFF THE LOOP. THE DOCTOR SEVERED THE HANDLE OF THE SUBJECT DEVICE, AND WITHDREW THE ONLY SCOPE FROM THE PATIENT. AFTER THAT, THE DOCTOR INSERTED THE SCOPE AGAIN, CUT THE LOOP WITH ANOTHER DEVICE, AND COMPLETED THE INTENDED PROCEDURE. AT THE SAME TIME, THE DOCTOR COULD WITHDRAW THE REMAINING PARTS OF THE SUBJECT DEVICE, WHICH COULDN'T COME OFF THE LOOP, FROM THE PATIENT. THE PATIENT LEFT THE HOSPITAL ON THE SAME DAY. THERE WAS NO OTHER PATIENT INJURY REGARDING THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718080 LOOP CUTTER LOOP CUTTER JYA OLYMPUS MEDICAL SYSTEMS CORP. FS-5Q-1 0YK

    Patients

    Seq Age Sex Outcome Treatment
    1