BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOSURG CURVED SCISSORS,HF,PISTOL GRIP,5MM X 34CM

    MDR report key: 9656951 · Received February 2, 2020

    Report

    Report Number
    8010047-2020-01056
    Event Type
    Malfunction
    Date Received
    February 2, 2020
    Date of Event
    December 19, 2019
    Report Date
    February 3, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    LFL
    PMA / PMN Number
    K050885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE COATING FOR ELECTRIC INSULATION OF THE INSERTION SECTION WAS PARTIALLY MISSING AT ABOUT 75 MM AND 90 MM FROM THE DISTAL END. THERE WERE MULTIPLE SCRATCHES AROUND THOSE MISSING POINTS. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. BASED ON THE PAST SIMILAR CASES, IT WAS KNOWN THAT THE COATING FOR ELECTRIC INSULATION OF THE INSERTION SECTION WAS DAMAGED WHEN IT CONTACTED WITH OTHER SHARP INSTRUMENTS DURING PROCEDURE OR REPROCESSING. THE ABOVE DEVICE HANDLING HAS BEEN WARNED IN THE INSTRUCTION MANUAL AS FOLLOWS; SHOULD ANY IRREGULARITY BE OBSERVED (WITH THE REPROCESSING EQUIPMENT), USE A SPARE INSTRUMENT INSTEAD. USING DEFECTIVE REPROCESSING EQUIPMENT MAY MAKE IT IMPOSSIBLE TO EFFECTIVELY REPROCESS THE INSTRUMENTS, AND COULD CAUSE INSTRUMENT DAMAGE. WHEN INSERTING THE INSTRUMENT INTO OR REMOVING IT OUT OF THE TROCAR TUBE, DO NOT APPLY EXCESSIVE FORCE. IF THE INSTRUMENTS IS DIFFICULT TO INSERT, EXTRACT IT FROM THE TROCAR TUBE AND MAKE SURE THAT IT IS NOT DAMAGED. ATTEMPTING TO INSERT OR REMOVE THE INSTRUMENT WITH EXCESSIVE FORCE MAY CAUSE DAMAGE AND/OR MAKE IT IMPOSSIBLE TO REMOVE THE INSTRUMENT FROM THE TROCAR TUBE. WHEN USING THE INSTRUMENT IN COMBINATION WITH THE TROCAR, DO NOT APPLY STRONG BENDING PRESSURE TO THE INSERTION SECTION. IF THE INSTRUMENT COMES IN STRONGLY CONTACT WITH THE OPENING OF THE TROCAR TUBE¿S INSERTION SECTION, IT COULD CAUSE THE INSULATION ON THE INSTRUMENT¿S INSERTION SECTION TO PEEL OFF AND/OR CAUSE OTHER DAMAGE TO THE INSTRUMENT.

    Description of Event or Problem · 1

    DURING AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE WAS USED. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SUBJECT DEVICE. WHILE CLEANING THE SUBJECT DEVICE AFTER THE PROCEDURE, THE USER FOUND THAT THE BLACK COATING OF THE INSERTION SECTION WAS PARTIALLY PEELED. THERE WAS NO PATIENT INJURY REPORTED. ON JANUARY 8, 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE COATING OF THE INSERTION SECTION FOR ELECTRIC INSULATION WAS PARTIALLY MISSING. THIS IS THE REPORT REGARDING THE MISSING OF THE INSERTION SECTION COATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120098 SONOSURG CURVED SCISSORS,HF,PISTOL GRIP,5MM X 34CM ULTRASONIC SURGICAL DEVICE LFL OLYMPUS MEDICAL SYSTEMS CORP. T3905

    Patients

    Seq Age Sex Outcome Treatment
    1