BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 1070787 · Received July 3, 2008

    Report

    Report Number
    1056128-2008-00047
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 2, 2008
    Report Date
    July 3, 2008
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    NLQ
    PMA / PMN Number
    K043225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE INSTRUMENT WAS VISUALLY INSPECTED (UNAIDED AND MICROSCOPICALLY AIDED) AND FOUND TO HAVE ITS JAW (PAD/ARM SUBASSEMBLY) DETACHED. THE PRONGS OR HINGE STRUCTURES LOCATED AT THE DISTAL END OF BOTH THE EXTERNAL AND ACTUATING SHAFTS WERE FOUND TO BE VISIBLY BENT OUTWARDS RELATIVE TO THE SCALPEL ROD. THE PRONGS ON THE DETACHED JAW COULD NOT BE EXAMINED SINCE THAT PART WAS NOT RETURNED WITH THIS DEVICE. THERE WAS A CRACK NOTICED ON THE DISTAL END OF THE SCALPEL ROD. THE RETURNED SCALPEL WAS ATTACHED TO OUR SCALPEL GENERATOR USING A MATCHING HAND-PIECE AND TESTED. IT WAS OBSERVED TO FAIL THIS TEST. THE POSSIBLE REASON FOR THIS FAILURE COULD BE THE CRACK OBSERVED ON THE DISTAL END OF THE SCALPEL ROD. THE DAMAGE SEEN ON THE SCALPEL ROD INDICATES DEVICE CONTACT WITH A HARD OBJECT; HOWEVER, WE WERE UNABLE TO CONCLUSIVELY DETERMINE A CAUSE FOR THE ISSUE EXPERIENCED AT THE CUSTOMER'S FACILITY. THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS IN PROPER OPERATING CONDITION PRIOR TO RELEASE.

    Description of Event or Problem · 1

    DURING PROCEDURE, PHYSICIAN WAS USING A HARMONIC SCALPEL WHEN PART OF THE JAW DETACHED INTO SURGICAL SITE. THE JAW WAS RETRIEVED AND THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NLQ ASCENT HEALTHCARE SOLUTIONS LCSC5 143575

    Patients

    Seq Age Sex Outcome Treatment
    1