BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3955873 · Received July 24, 2014

    Report

    Report Number
    0001056128-2014-00085
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NLQ
    PMA / PMN Number
    K043315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR AN EVALUATION. VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED EVIDENCE OF CLINICAL USE INCLUDING BIOLOGICAL MATERIAL ON THE DISTAL TIP AS WELL AS AN INDENTATION IN THE TEFLON PAD. VISUAL INSPECTION ALSO CONFIRMED THE REPORTED ISSUE AS THE BLADE WAS BROKEN OFF. A REVIEW OF THE LOT CONTROL SHEET FOR THE REPORTED DEVICE INDICATED THE DEVICE PASSED ALL INSPECTIONS PRIOR TO RELEASE FROM SSS. THE RESULTS OF THE INVESTIGATION PERFORMED INDICATED THAT THE BLADE OF RETURNED DEVICE BROKE AS A RESULT OF THE BLADE CONTACTING A HARD OBJECT, POSSIBLY A STAPLE OR SURGICAL CLIP, DURING CLINICAL USE (I.E. END USER TECHNIQUE CONTRARY TO THE IFU). STRYKER SUSTAINABILITY SOLUTIONS' INSTRUCTIONS FOR USE STATE: "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 DURING THE PROCEDURE, "THE ACE6E EMITTED TWO ERROR CODES, ONE FOR 'TIGHTEN HAND PIECE' AND ONE FOR 'BLADE'." THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH MINIMAL DELAY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432973 NA SCALPEL, ULTRASONIC, REPROCESSED NLQ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND ACE36E 2869441

    Patients

    Seq Age Sex Outcome Treatment
    1