BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2201369 · Received August 11, 2011

    Report

    Report Number
    1056128-2011-00075
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    NLQ
    PMA / PMN Number
    K043358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE TEFLON PAD HAD AN INDENTION, THE BLADE AND JAW WERE BOTH BROKEN OFF AND RETURNED, AND THE BLADE FRACTURE ORIGINATED FROM A GOUGE. BASED ON THE DAMAGE OBSERVED, THE MOST LIKELY CAUSE FOR THE REPORT WAS DETERMINED TO BE AN IMPACT OF THE JAW WITH A SOLID SURFACE OR OBJECT. 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." A REVIEW OF THE LOT CONTROL SHEET FOR THE REPORTED DEVICE SERIAL NUMBER INDICATED THE DEVICE PASSED ALL INSPECTIONS. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAN ABOUT AN HOUR INTO THE PROCEDURE THE ULTRASONIC SCALPEL WAS HAVING "MECHANICAL PROBLEMS." THE DEVICE WAS REMOVED FROM THE PATIENT AND CLEANED. AS THE DEVICE WAS BEING CLEANED, HALF OF THE JAW BROKE OFF OF THE DEVICE. ANOTHER SCALPEL WAS RETRIEVED TO COMPLETE THE PROCEDURE AND NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLQ NLQ STRYKER SUSTAINABILITY SOLUTIONS LCSC5 1011791

    Patients

    Seq Age Sex Outcome Treatment
    1