BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOSURG SCISSORS 5MM O.D. HF SERIES

    MDR report key: 6042774 · Received October 19, 2016

    Report

    Report Number
    8010047-2016-01306
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 19, 2016
    Report Date
    October 20, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    LFL
    PMA / PMN Number
    K021962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDLE OF THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE PTFE PAD OF THE SUBJECT DEVICE WAS SEVERELY WORN. THERE WAS A SCRATCH ON THE NON-INSULATED AREA WITH THE WORN PAD. AS THE RESULT OF CHECKING THE MANUFACTURING RECORD OF THE SUBJECT DEVICE, THERE WAS NOTHING ABNORMAL DETECTED. THIS TYPE OF THE PAD DAMAGE IS MOST LIKELY RELATED TO THE OPERATOR'S TECHNIQUE. BASED ON THE EVALUATION OF THE SUBJECT DEVICE AND THE SIMILAR CASES IN THE PAST, THE WEARING OF THE PTFE PAD MIGHT BE CAUSED BY ACTIVATION WHILE GRASPING NOTHING. THE INSTRUCTION MANUAL OF THE DEVICE ALREADY CAUTIONS; DO NOT ACTIVATE OUTPUT IN SEAL & CUT MODE WHILE THE GRASPING SECTION IS CLOSED WITHOUT CONTACTING TISSUE OR VESSEL, OR ENSURING THAT TISSUE IS TRANSECTED. OTHERWISE, A LOCAL INCREASE OF THE TEMPERATURE DUE TO A FRICTION BETWEEN THE PROBE TIP AND THE GRASPING SECTION MAY RESULT IN VARIOUS FORMS OF DAMAGE IN THE PROBE TIP AND/OR THE TISSUE PAD, SUCH AS PREMATURE WEAR, BREAKAGE, DEFORMATION, AND/OR FALLING OFF INSIDE THE BODY CAVITY AND/OR PARTIAL SEPARATING.

    Description of Event or Problem · 1

    AFTER THE PROCEDURE, THE DOCTOR FOUND THAT THE PTFE PAD OF THE SUBJECT DEVICE WAS WORN. DETAILS OF THE PROCEDURE WERE UNKNOWN. NO PATIENT INJURY WAS REPORTED. ON (B)(6) 2016, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) CONFIRMED THAT THE PTFE PAD WAS SEVERELY WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690156 SONOSURG SCISSORS 5MM O.D. HF SERIES SONOSURG HANDPIECE LFL OLYMPUS MEDICAL SYSTEMS CORP. T3920

    Patients

    Seq Age Sex Outcome Treatment
    1