BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE LIGATING DEVICE

    MDR report key: 5772879 · Received July 6, 2016

    Report

    Report Number
    2951238-2016-00580
    Event Type
    Malfunction
    Date Received
    July 6, 2016
    Date of Event
    June 17, 2016
    Report Date
    March 8, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FHN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS 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 RESULTS.. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT MAY BE ATTRIBUTED TO USER HANDLING. THE INSTRUCTION MANUAL CONTAINS SEVERAL WARNING STATEMENTS IN AN EFFORT TO PREVENT THE POLYLOOP DEVICE FROM GETTING STUCK INSIDE THE SHEATH. ¿BEFORE USE, PREPARE AND INSPECT THE INSTRUMENT AS INSTRUCTED BELOW. SHOULD THE SLIGHTEST IRREGULARITY BE SUSPECTED, DO NOT USE THE INSTRUMENT; USE A SPARE INSTEAD. DAMAGE OR IRREGULARITY MAY COMPROMISE PATIENT OR USER SAFETY AND MAY RESULT IN MORE SEVERE EQUIPMENT DAMAGE. DO NOT STRIKE OR CRUSH THE COIL SHEATH DURING OPERATION. DOING SO CAN DAMAGE THE DISTAL END OF THE COIL SHEATH, WHICH COULD MAKE IT IMPOSSIBLE TO DETACH THE LOOP AFTER LIGATION."

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC UNSPECIFIED PROCEDURE, THE LOOP BECAME STUCK IN THE PATIENT. IT IS UNKNOWN HOW THE LOOP WAS RETRIEVED. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. REPORTEDLY THE PATIENT HAD A POSITIVE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427696 SINGLE USE LIGATING DEVICE SINGLE USE LIGATING DEVICE FHN OLYMPUS MEDICAL SYSTEMS CORP. HX-400U-30 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1