BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE LIGATING DEVICE

    MDR report key: 6682695 · Received June 30, 2017

    Report

    Report Number
    2951238-2017-00433
    Event Type
    Malfunction
    Date Received
    June 30, 2017
    Date of Event
    June 5, 2017
    Report Date
    March 8, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FHN
    PMA / PMN Number
    PK980465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM FDT TO FHN.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT BUT WITH NO RESULT. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME; HOWEVER, BASED ON SIMILAR REPORTS THIS TYPE OF ISSUE OCCURS WHEN THE LOOP IS CAUGHT BETWEEN THE HOOP AND THE COIL SHEATH. THE DEVICE INSTRUCTION MANUAL WARNS USERS "WHEN REMOVING THE HOOK FROM THE LOOP, CONFIRM ON THE ENDOSCOPIC IMAGE THAT THE COIL SHEATH IS EXTENDED FROM THE TUBE SHEATH. OTHERWISE, THE LOOP MAY GET STUCK INSIDE THE CHANNEL."

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A MEDWATCH (B)(4) WHICH REPORTS THAT DURING A COLONOSCOPY PROCEDURE THE POLYLOOP WOULD NOT RELEASE PROPERLY. THE PHYSICIAN CUT THE HANDLE TO REMOVE THE SCOPE. A SECOND SCOPE WAS UTILIZED TO RETRIEVE THE ENTIRE POLYLOOP AND A PORTION OF THE POLYP. IT IS UNKNOWN IF THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463149 SINGLE USE LIGATING DEVICE SINGLE USE LIGATING DEVICE FHN OLYMPUS MEDICAL SYSTEMS CORP. HX-400U-30 68V

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR