BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 3981497 · Received August 5, 2014

    Report

    Report Number
    0001056128-2014-00088
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NLQ
    PMA / PMN Number
    K043315
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 CONFIRMED THE REPORTED ISSUE AS THE BLADE WAS BROKEN OFF. 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). "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.¿ A REVIEW OF THE LOT CONTROL SHEET FOR THE REPORTED DEVICE INDICATED THE DEVICE PASSED ALL INSPECTIONS PRIOR TO RELEASE FROM SSS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, "A PIECE OF THE TIP BROKE OFF THE ACE45 DEVICE." THE FACILITY SEARCHED THE FLOOR AND TOOK AN X-RAY, BUT THEY WERE UNABLE TO LOCATE THE PIECE. ALTHOUGH THE FACILITY WAS UNSURE OF THE EXACT LENGTH OF SURGICAL DELAY, THEY STATED THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456491 NA SCALPEL, ULTRASONIC, REPROCESSED NLQ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND ACE45E 2654969

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention