BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGERY PROBE PLUS II

    MDR report key: 2983141 · Received February 28, 2013

    Report

    Report Number
    3005075853-2013-00936
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K912492
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDED ADDITIONAL INFORMATION THE CUSTOMER COMPLAINT INDICATED THAT THERE WAS DAMAGE ON THE TYVEK. ONE SALES UNIT CARTON WAS RETURNED WITH SIX SEALED PACKAGES. THE CARTON AND PACKAGES WERE SEPARATED AND THE SUSPECT PACKAGE WAS POUCHED SEPARATELY IN BUBBLE-WRAP. THE CARTON HAD SLIGHT CRUSH/COMPRESSION DAMAGE. EACH PACKAGE WAS VISUALLY INSPECTED. ON VISUAL INSPECTION, IT WAS CONFIRMED THAT ONE PACKAGE HAD A SMALL HOLE ALIGNED OVER THE DEVICE KNOB FIN. THE HOLE WAS CONFIRMED BY USING DYE TEST. THE REMAINING FIVE PACKAGES EXHIBITED NO DAMAGE. THE DEFECT CHARACTERISTICS APPEAR INDICATIVE OF DAMAGE CAUSED FROM THE INSIDE OF THE PACKAGE OUTWARDS RATHER THAN DAMAGE THAT WAS CAUSED FROM THE OUTSIDE-INTO THE PACKAGE. BASED ON THE INVESTIGATION, IT IS NOT POSSIBLE TO DETERMINE HOW THE DAMAGE TO THE PACKAGE OCCURRED.

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE INCOMING/LABELING OPERATION AT THE AFFILIATE OFFICE, DAMAGED WAS NOTICED ON THE TYVEK. THE DEVICE WAS NOT AT A HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87438 ELECTROSURGERY PROBE PLUS II LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. UNK K4C49K

    Patients

    Seq Age Sex Outcome Treatment
    1