BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 6136834 · Received November 30, 2016

    Report

    Report Number
    0001056128-2016-00156
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 2, 2016
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NLQ
    UDI-DI
    00885825017347
    PMA / PMN Number
    K133672
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. UPON VISUAL INSPECTION OF THE RECEIVED COMPLAINT DEVICE, THE DEVICE REVEALED EVIDENCE OF CLINICAL USE AND A LARGE INDENTATION IN THE TEFLON PAD. THE TEFLON PAD WAS MELTED AND PART OF THE TEFLON PAD TIP WAS DETACHED FROM THE JAW. A REVIEW OF THE DHR SUPPORTS THAT THE DEVICE MET ALL INSPECTION AND TEST CRITERIA PRIOR TO RELEASE FROM STRYKER. THEREFORE, THE MOST LIKELY ROOT CAUSES ARE: APPLYING PRESSURE BETWEEN INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM PROLONGED ACTIVATION (IN GENERAL OR AGAINST SOLID SURFACES) REPEATED USE OF INSTRUMENT BEYOND INTENDED USE. THE INSTRUCTIONS FOR USE (IFU) STATE: CARE SHOULD BE TAKEN NOT TO APPLY PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM. CLAMPING THE TISSUE PAD AGAINST THE ACTIVE BLADE WITHOUT TISSUE ON THE FULL LENGTH OF THE BLADE WILL RESULT IN HIGHER BLADE, CLAMP ARM AND DISTAL SHAFT TEMPERATURES AND CAN RESULT IN POSSIBLE DAMAGE TO THE INSTRUMENT. IF THIS OCCURS, THERE MAY BE AN INSTRUMENT FAILURE, AND THE GENERATOR TOUCHSCREEN DISPLAYS A TROUBLESHOOTING MESSAGE. FOR OPTIMAL PERFORMANCE AND TO AVOID TISSUE STICKING, CLEAN THE INSTRUMENT BLADE, CLAMP ARM, AND DISTAL END OF THE SHAFT THROUGHOUT THE PROCEDURE BY ACTIVATING THE INSTRUMENT TIP IN SALINE. NOTE: DO NOT TOUCH THE INSTRUMENT TO METAL WHILE ACTIVATED. NOTE: DO NOT CLEAN THE BLADE TIP WITH ABRASIVES. IT CAN BE WIPED WITH A MOIST GAUZE SPONGE TO REMOVE TISSUE, IF NECESSARY. IF TISSUE IS STILL VISIBLE IN THE CLAMP ARM, USE HEMOSTATS TO REMOVE RESIDUE, TAKING CARE NOT TO ACTUATE THE HAND PIECE. IF DESIRED, THE INSTRUMENT MAY BE UNPLUGGED. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST-MARKET SURVEILLANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE HARMONIC SCALPEL MELTED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788006 NA SCALPEL, ULTRASONIC, REPROCESSED NLQ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND HAR36 4693580 00885825017347

    Patients

    Seq Age Sex Outcome Treatment
    1