BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELECTROSURGERY PROBE PLUS II

    MDR report key: 1215513 · Received October 29, 2008

    Report

    Report Number
    3005075853-2008-02609
    Event Type
    Other
    Date Received
    October 29, 2008
    Date of Event
    September 29, 2008
    Report Date
    September 29, 2008
    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

    DATE SENT: 10/29/2008. ADDITIONAL LOT NUMBER: E4M20V. MALFUNCTION. EVALUATION SUMMARY - THE INVESTIGATION INTO THIS COMPLAINT REVEALED THAT THE INCORRECT BATCH# WAS PRINTED ON TYVEK. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO PROTOCOLS, DEFECTS, NON-CONFORMANCE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED MIXED LOT PRODUCTS ON EPS02 WERE FOUND. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROSURGERY PROBE PLUS II GCJ ETHICON ENDO-SURGERY, LLC NA E4LX4H

    Patients

    Seq Age Sex Outcome Treatment
    1