BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL CURVED SHEARS, SCISSOR-GRIP HANDLE - 14 CM

    MDR report key: 1150953 · Received August 28, 2008

    Report

    Report Number
    3005075853-2008-01411
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Report Date
    August 20, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THERE WERE A TOTAL OF 12 PIECES (2 SALES UNITS) RECEIVED. OF THE 12 PIECES RETURNED, 2 OF THE 12 PIECES HAD CREASES OF VARYING DEGREE PRESENT ON THE PACKAGE. HOWEVER, DURING ANALYSIS AND DYE TEST, IT WAS FOUND THAT THE CREASES IN THE PACKAGES DID NOT AFFECT THE STERILITY OF THE PACKAGES. ALL OF THE QUESTIONABLE PACKAGES WERE OPENED AND IT WAS CONFIRMED THAT THERE WAS HEAT SEAL TRANSFER PRESENT ON ALL OF THE PACKAGES, INDICATING THAT THE STERILITY OF THE PACKAGES HAD NOT BEEN BREACHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PACKAGES WITH CHANNELS ON THE SEAL AREA WERE FOUND AT INCOMING INSPECTION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC SCALPEL CURVED SHEARS, SCISSOR-GRIP HANDLE - 14 CM GEI ETHICON ENDO-SURGERY, LLC NA E4L539

    Patients

    Seq Age Sex Outcome Treatment
    1 NA