BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 6239369 · Received January 10, 2017

    Report

    Report Number
    0001056128-2017-00006
    Event Type
    Malfunction
    Date Received
    January 10, 2017
    Date of Event
    April 29, 2016
    Report Date
    January 10, 2017
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NLQ
    UDI-DI
    00885825014766
    PMA / PMN Number
    K043315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A REVIEW OF THE MAUDE DATABASE, MDR REPORT # 5670947 WAS DISCOVERED WHICH ALLEGED A MALFUNCTION OCCURRED FOR A HARMONIC HANDPIECE DEVICE FROM STRYKER INSTRUMENTS, LOT # 4110409. IT IS KNOWN THAT STRYKER INSTRUMENTS DOES NOT MANUFACTURE THESE TYPES OF DEVICES. A SEARCH OF THE LOT # REVEALED THE DEVICE WAS REPROCESSED BY STRYKER SUSTAINABILITY SOLUTIONS. THE DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION AND THE REPORTER FACILITY IS UNKNOWN. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, VISUAL AND FUNCTIONAL INSPECTION WAS UNABLE TO BE PERFORMED. A REVIEW OF THE DHR FOR THE REPORTED LOT NUMBER SUPPORTS THAT THE DEVICE MET ALL INSPECTION AND TEST CRITERIA PRIOR TO RELEASE FROM STRYKER. THE REPORTED EVENT MAY BE ATTRIBUTED TO: - SHIPPING DAMAGE, HANDLING DAMAGE SUBSEQUENT TO DISTRIBUTION FROM STRYKER SUSTAINABILITY SOLUTIONS - 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: - TAKE CARE TO AVOID APPLICATION OF PRESSURE BETWEEN THE BLADE AND TISSUE PAD WITHOUT TISSUE IN BETWEEN THEM AS THIS CAN RESULT IN DAMAGE TO THE INSTRUMENT. THIS MAY CAUSE A SYSTEM FAILURE SIGNALED BY A CONTINUOUS BEEP WHEN EITHER OF THE FOOT PEDALS IS DEPRESSED. - AVOID CONTACT WITH ANY AND ALL METAL OR PLASTIC INSTRUMENTS OR OBJECTS DURING INSTRUMENT ACTIVATION. CONTACT WITH STAPLES, CLIPS, OR OTHER INSTRUMENTS DURING INSTRUMENT ACTIVATION MAY RESULT IN PREMATURE BLADE FAILURE, RESULTING IN GENERATOR SOLID TONE OR INSTRUMENT ERROR. - CLEAN BLADE, CLAMP ARM, AND DISTAL END OF SHAFT THROUGHOUT PROCEDURE TO ACHIEVE OPTIMAL PERFORMANCE AND TO AVOID TISSUE STICKING BY ACTIVATING THE INSTRUMENT TIP IN SALINE. NOTE: DO NOT CLEAN BLADE TIP WITH ABRASIVES. INSTEAD, WIPE WITH MOIST GAUZE SPONGE TO REMOVE TISSUE. IF TISSUE IS STILL VISIBLE, USE HEMOSTATS TO REMOVE RESIDUE WITH GENERATOR IN STANDBY MODE. SHOULD INFORMATION ON THE REPORTER FACILITY BECOME KNOWN, THE INVESTIGATION WILL BE REOPENED. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST-MARKET SURVEILLANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE HARMONIC SCALPEL CONSOLE ALARMED AND VISUALLY STATED TO REMOVE FROM THE PATIENT. IT WAS REMOVED AND THEN THE MACHINE STATED TO CLEAN THE TIPS. THE TIPS WERE CLEANED WHILE THE SHEERS WERE REMOVED AND A PIECE OF THE SHEERS BROKE OFF WHILE CLEANING. 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
    21808 NA SCALPEL, ULTRASONIC, REPROCESSED NLQ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND ACE14S 4110409 00885825014766

    Patients

    Seq Age Sex Outcome Treatment
    1