BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 4112254 · Received September 23, 2014

    Report

    Report Number
    0001056128-2014-00106
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NLQ
    PMA / PMN Number
    K043315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 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). "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.¿ THIS REPORT IS BEING FILED AS A MALFUNCTION DUE TO SSS BEING IN A 2 YEAR REPORTING CYCLE DUE TO AN EVENT IN WHICH THE TIP BROKE OFF OF THE DEVICE AND X-RAY WAS USED TO ENSURE NO REMNANTS OF THE DEVICE WERE LEFT IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLECTOMY, ONE OF THE TIPS BROKE OFF INTO THE PATIENT. THE PIECE WAS RETRIEVED WITHOUT ANY COMPLICATIONS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES, MEDICAL INTERVENTION, OR SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591659 NA SCALPEL, ULTRASONIC, REPROCESSED NLQ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND ACE45E 2846831

    Patients

    Seq Age Sex Outcome Treatment
    1