BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2103613 · Received May 26, 2011

    Report

    Report Number
    1056128-2011-00041
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 29, 2011
    Report Date
    May 2, 2011
    Manufacturer
    ASCENT
    Product Code
    NLQ
    PMA / PMN Number
    K043315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 SOLIDSURFACE OR OBJECT. ASCENT'S 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 DURING THE PROCEDURE THE DISTAL TIP OF THE ULTRASONIC SCALPEL BROKE OFF INTO HE PATIENT. THE PIECE WAS EASILY RETRIEVED AND THERE WAS NOT PATIENT INJURY REPORTED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLQ NLQ ASCENT ACE23E 1440308

    Patients

    Seq Age Sex Outcome Treatment
    1