BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOOP CUTTER

    MDR report key: 3941529 · Received April 17, 2014

    Report

    Report Number
    8010047-2014-00167
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 24, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT PRODUCT WAS RETURNED TO OMSC FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THAT THE LOOP GOT CAUGHT IN THE DISTAL END OF THE DEVICE AND THE CUTTER COULD NOT OPEN. IN ADDITION, THE LOOP COULD NOT BE REMOVED FROM THE CUTTER. THE LOT NUMBER WAS UNCLEAR. HOWEVER, AS THE RESULT OF CHECKING THE MANUFACTURING RECORD OF THE ALL LOTS WHICH HAD BEEN DELIVERED TO THE FACILITY, NOTHING ABNORMAL DETECTED. OMSC ASSUMES THAT THE LOOP WAS NO POSITIONED CORRECTLY ON THE LOOP HANGER AND THE LOOP GOT STUCK IN THE LOOP HANGER OF THE PRODUCT. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MED SYS CORP (OMSC) WAS INFORMED THAT DURING COLONOSCOPY THE DOCTOR ATTEMPTED TO CUT A LOOP BUT IT WAS STUCK IN THE CUTTER. THE DOCTOR COULD NOT TEMPORARILY WITHDRAW THE SUBJECT DEVICE FROM THE PT. THE DOCTOR CUT THE INSERTION PORTION WITH A NIPPER AND CUT THE LOOP USING SPARE LOOP CUTTER AS DESCRIBED IN THE INSTRUCTION MANUAL. THEN, HE COULD WITHDRAW THE DEVICE FROM THE PT. THERE WAS NO REPORT OF PT INJURY REGARDING THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236498 LOOP CUTTER LOOP CUTTER FDF OLYMPUS MEDICAL SYSTEMS CORPORATION FS-5Q-1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1