BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 4926633 · Received July 20, 2015

    Report

    Report Number
    0001056128-2015-00063
    Event Type
    Malfunction
    Date Received
    July 20, 2015
    Date of Event
    March 23, 2015
    Report Date
    June 15, 2015
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NLQ
    PMA / PMN Number
    K043315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR EVALUATION. INSPECTION OF THE RETURNED DEVICE REVEALED BIOLOGICAL MATERIAL ON THE DISTAL TIP AND AN INDENTATION IN THE TEFLON PAD. THE DEVICE WAS ACTUATED MULTIPLE TIMES, AND INITIALLY THE JAWS WOULD NOT CLOSE. AFTER CLEANING WITH SALINE, THE DEVICE WAS ACTUATED MULTIPLE TIMES AND CONFIRMED TO HAVE PROPER MECHANICAL FUNCTIONALITY. THE DEVICE WAS CONNECTED TO A GENERATOR AND FAILED WITH TWO "TIGHTEN ASSEMBLY" ERRORS (AFTER WHICH THE ASSEMBLY WAS TIGHTENED) AND A "REPLACE INSTRUMENT" ERROR. THE ROD WAS INSPECTED FOR FRACTURES A CRACK IN THE BLADE WAS FOUND. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THE DEVICE MET ALL INSPECTION AND TEST CRITERIA PRIOR TO RELEASE. THEREFORE, THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT IS THE BLADE CONTACTING A HARD OBJECT, POSSIBLY A STAPLE OR SURGICAL CLIP, OR OVERTIGHTENING THE INSTRUMENT DURING CLINICAL USE. THE INSTRUCTIONS FOR USE FOR HARMONIC ACE CURVED SHEARS 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.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ACE45E SCALPEL STOPPED WORKING. THERE WAS NO SURGICAL DELAY, MEDICAL INTERVENTION, OR ADVERSE CONSEQUENCES REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470045 NA SCALPEL, ULTRASONIC, REPROCESSED NLQ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND ACE45E 3363820

    Patients

    Seq Age Sex Outcome Treatment
    1