BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2141844 · Received June 28, 2011

    Report

    Report Number
    1056128-2011-00055
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 2, 2011
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    NLQ
    PMA / PMN Number
    K043315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 TIP OF THE BLADE WAS BROKEN OFF AND THE BLADE EXHIBITED A GOUGE AT THE FRACTURE SITE. 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 PRIOR TO RELEASE. 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 THAT THE ULTRASONIC SCALPEL HAD NOT BEEN ACTIVATING DURING A PROCEDURE. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THE BLADE OF THE SCALPEL BROKE OFF. NOTHING FELL INTO THE PATIENT AND THERE WAS NO PATIENT INJURY REPORTED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLQ NLQ STRYKER SUSTAINABILITY SOLUTIONS ACE36E 1541975

    Patients

    Seq Age Sex Outcome Treatment
    1