BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE LIGATING DEVICE

    MDR report key: 7374291 · Received March 27, 2018

    Report

    Report Number
    2951238-2018-00214
    Event Type
    Malfunction
    Date Received
    March 27, 2018
    Date of Event
    March 12, 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
    MA, US
    Reporter Occupation
    NURSE

    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 DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THEREFORE, THE CAUSE OF THE REPORTED DEVICE BREAKAGE COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. BASED ON SIMILAR REPORTED EVENTS, THE OPERATOR¿S TECHNIQUE COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR TO THE REPORTED EVENT. THE INSTRUCTION MANUAL CONTAINS WARNING AND CAUTION STATEMENTS IN AN EFFORT TO MITIGATE DEVICE DAMAGE AND PATIENT INJURY. ¿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 A THERAPEUTIC POLYPECTOMY PROCEDURE, THE POLYLOOP SHEATH COVER FROM THE HANDLE OF THE DEVICE BROKE OFF AND FELL INSIDE THE PATIENT WHEN THE PHYSICIAN WAS ATTEMPTING TO LIGATE A POLYP IN THE PATIENT¿S RECTUM. IT WAS FURTHER REPORTED THAT THE DEVICE ISSUE OCCURRED WHEN THE DEVICE SLIDER WAS BEING MOVED FORWARD TO RELEASE THE LOOP. THE DEVICE FRAGMENT WAS RETRIEVED FROM THE PATIENT. IN ADDITION, THE ENTIRE DEVICE WAS REMOVED FROM THE PATIENT BY CUTTING AT THE PROXIMAL END TO DETACH THE HANDLE. SUBSEQUENTLY, AN ENDOLOOP WIRE WAS USED TO CLIP THE LOOP AT THE DISTAL END. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217703 SINGLE USE LIGATING DEVICE SINGLE USE LIGATING DEVICE FHN OLYMPUS MEDICAL SYSTEMS CORP. HX-400U-30 77V

    Patients

    Seq Age Sex Outcome Treatment
    1