BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE LIGATING DEVICE

    MDR report key: 8201471 · Received December 27, 2018

    Report

    Report Number
    2951238-2018-00815
    Event Type
    Malfunction
    Date Received
    December 27, 2018
    Date of Event
    December 4, 2018
    Report Date
    March 8, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FHN
    UDI-DI
    04953170368615
    PMA / PMN Number
    K980465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE DEVICE EVALUATION RESULTS. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THE COMPLAINT FOR THE DEVICE BROKEN IN HALF. ONLY THE HANDLE PORTION WAS RETURNED WITH THE INSERTION PORTION COIL SHEATH, LOOP WIRE AND LOT NUMBER PLATE MISSING. THE MANIPULATION WIRE ON THE HANDLE WAS SEVERELY BENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED COMPLAINT CANNOT BE CONFIRMED. AS MITIGATION FOR A STUCK DEVICE, THE DEVICE INSTRUCTION MANUAL CONTAINS EMERGENCY TREATMENT DIRECTIONS FOR REMOVING THE DEVICE. THE PHYSICIAN DID REMOVE THE REST OF THE DEVICE USING STEPS DESCRIBED IN THE INSTRUCTIONS. THE INSTRUCTION MANUAL STATES THAT TO PREPARE FOR EMERGENCY TREATMENT, ¿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 HAS DIRECTIONS FOR PRE-PROCEDURE INSPECTION OF THE DEVICE, AND STATES THAT TO AVOID DEVICE DAMAGE, ¿DO NOT ADVANCE OR EXTEND THE INSTRUMENT ABRUPTLY.¿ AND ¿DO NOT FORCE THE INSTRUMENT IF RESISTANCE TO INSERTION IS ENCOUNTERED.¿.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A POLYPECTOMY, THE PHYSICIAN CLOSED THE DEVICE LOOP AROUND THE POLYP AND TRIED TO DEPLOY THE LOOP. THE METAL CONNECTING THE THUMB RING TO THE SPOOL THEN SNAPPED IN HALF, AT THE PROXIMAL END IN THE HANDLE. THIS PREVENTED THE LOOP FROM DEPLOYING FROM THE REST OF THE DEVICE. TO REMOVE THE DEVICE, THE PHYSICIAN CUT THE HANDLE OFF THE DEVICE, EXCHANGED THE SCOPE OVER THE DEVICE, AND USED THE SEPARATE LOOP CUTTER THROUGH THE SCOPE TO CUT THE LOOP AWAY FROM THE PROXIMAL REMAINDER OF THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL BLEEDING. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME MODEL POLYLOOP DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038074 SINGLE USE LIGATING DEVICE SINGLE USE LIGATING DEVICE FHN OLYMPUS MEDICAL SYSTEMS CORP. HX-400U-30 85V 04953170368615

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN MODEL ENDOSCOPE| UNKNOWN MODEL LOOP CUTTER