BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE LIGATING DEVICE

    MDR report key: 7217053 · Received January 24, 2018

    Report

    Report Number
    2951238-2018-00067
    Event Type
    Malfunction
    Date Received
    January 24, 2018
    Date of Event
    January 11, 2018
    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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION, SO THE CAUSE OF THE REPORTED COMPLAINT CANNOT BE CONFIRMED. IT WAS ALSO REPORTED THAT THE DEVICE HAD NOT BEEN INSPECTED PRIOR TO THE PROCEDURE, CONTRARY TO THE INSTRUCTION MANUAL WHICH CONTAINS STEPS FOR PRE-PROCEDURE VISUAL AND TACTILE INSPECTION OF THE DEVICE. AS MITIGATION FOR A STUCK DEVICE, THE INSTRUCTION MANUAL CONTAINS EMERGENCY TREATMENT DIRECTIONS FOR REMOVING THE DEVICE: ¿ALWAYS HAVE THE OLYMPUS LOOP CUTTER (FS-5L/Q/U-1), PLIERS AND/OR WIRE CUTTERS READY TO CUT THE COIL SHEATH, TUBE SHEATH AND OPERATION WIRE IN CASE THE LOOP CANNOT BE DETACHED FROM THE INSTRUMENT.¿ AS PREVENTIVE MEASURES, THE INSTRUCTION MANUAL ALSO STATES, ¿ALWAYS HAVE A SPARE INSTRUMENT AVAILABLE¿ AND ¿USE THIS INSTRUMENT IN AN ENVIRONMENT EQUIPPED TO ACCOMMODATE OPEN SURGERY AND HAVE THE HOSPITALIZATION PLAN PREPARED IN CASE ANY PROBLEM OCCURS THAT MAY NOT BE RESOLVED ENDOSCOPICALLY.¿ THE INSTRUCTION MANUAL ALSO WARNS THAT THE LOOP MAY NOT DETACH IF USED WITH AN INCOMPATIBLE ENDOSCOPE, OR IF THE LOOP IS DEPLOYED TOO NEAR THE DISTAL END OF THE DEVICE TO AVOID TANGLING WITH THE HOOK.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNKNOWN PROCEDURE, THE LOOP OF THE DEVICE BECAME STUCK ON A POLYP AND WOULD NOT RELEASE. DIFFICULTY WAS REPORTED WITH OPERATING THE PROXIMAL PARTS OF THE DEVICE TO RELEASE THE LOOP. THE EMERGENCY TREATMENT STEPS PER THE INSTRUCTION MANUAL WERE ATTEMPTED BUT NOT COMPLETED. THE USER FACILITY EVENTUALLY DETACHED THE LOOP BY AN UNKNOWN METHOD AND COMPLETED THE PROCEDURE. THERE WAS NO REPORTED ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59015 SINGLE USE LIGATING DEVICE SINGLE USE LIGATING DEVICE FHN OLYMPUS MEDICAL SYSTEMS CORP. HX-400U-30 53V

    Patients

    Seq Age Sex Outcome Treatment
    1 190 SERIES OLYMPUS COLONOSCOPE