BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HS ACE 14 CM SCISSOR HANDLE

    MDR report key: 1002978 · Received February 4, 2008

    Report

    Report Number
    1527736-2008-00660
    Event Type
    Injury
    Date Received
    February 4, 2008
    Date of Event
    December 14, 2007
    Report Date
    January 11, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD CONDITION. THE DEVICE WAS TESTED WITH A GENERATOR AND WAS FUNCTIONAL, AND NO TEMPERATURE ISSUES WERE NOTED DURING 60 SECONDS OF ACTIVATION. THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THYROIDECTOMY PROCEDURE, THE PATIENT WAS BURNED WITH THE SHAFT OF THE DEVICE AT THE INCISION SITE. THE PROTECTIVE SLEEVE WAS PLACED CORRECTLY ON THE DISTAL END OF THE DEVICE AND THE PATIENT WAS BURNED THROUGH THE SLEEVE. THE BLADE TIP DID NOT SEEM HOTTER THAN NORMAL. THE BURN DID BLISTER AND HAS BEEN CLASSIFIED AS A 2ND DEGREE BURN. CREAM WAS ORDERED AND USED ON THE BURN. THE PATIENT IS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS ACE 14 CM SCISSOR HANDLE LFL ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4GJ11

    Patients

    Seq Age Sex Outcome Treatment
    1 YR PROTECTIVE SLEEVE| HANDPIECE| GENERATOR