BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 CURVED JAW

    MDR report key: 3844678 · Received June 3, 2014

    Report

    Report Number
    3005075853-2014-03728
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K112033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE COMPLAINT INDICATED UNREADABLE PRINTED LABEL. SIX INDIVIDUAL CARTONS WERE RETURNED FOR ANALYSIS. EACH OF THE CARTONS WAS VISUALLY INSPECTED AND FIVE WERE CONFIRMED TO HAVE LABEL DEFECTS. THE SIX LABELS WERE SEQUENCE NUMBERS 416, 417, 418, 419, 420, 421. LABEL 416 WAS CONFORMING. LABELS 417 THROUGH 421 EACH HAD A WHITE, UNPRINTED, VERTICAL LINE OF MISSING PRINT ON EACH ONE. THE LINE CAUSED ONE CHARACTER OF THE LOT NUMBER CHARACTERS TO NOT BE PRINTED. THE DEFECT WAS CAUSED BY A RIBBON FAULT. A WRINKLE IN THE RIBBON CAUSED THE UNPRINTED AREAS. DURING THE INVESTIGATION OF SIMILAR PAST EVENTS AND THE CONDITION OF THERMAL TRANSFER PRINTER RIBBON ON THE LINES, THE THERMAL TRANSFER RIBBON HAS BEEN FOUND TO HAVE WRINKLES WHERE THE RIBBON ATTACHES TO THE END-OF-ROLL FOIL. THE WRINKLES CAN AFFECT THE PRINT IN THE LAST LABELS PRINTED. NOT ALL RIBBON ROLLS HAVE WRINKLES, AND NOT ALL WRINKLES AFFECT THE PRINT. THE LOT HISTORY REVIEW FOUND NO PROTOCOLS, DEFECTS, NON-CONFORMANCES OR QUARANTINE RELATED TO COMPLAINT ISSUE. TIGHTENED INSPECTION WAS PERFORMED AND NO LABEL DEFECTS WERE FOUND. LOT HISTORY REVIEW WAS PERFORMED ON THE LOT PROCESSED IMMEDIATELY AFTER L4E73J. LOT L4E73H HAD NO PROTOCOLS, DEFECTS, NON-CONFORMANCES OR QUARANTINE AND NO COMPLAINTS. THE MACHINE LOG BOOK WAS CHECKED AND NO COMMENT ABOUT A PRINTER ISSUE WAS NOTED FOR LOT L4E73J OR ANY OTHER LOT ON THE DAY OF PACKAGING, WHICH WAS (B)(4) 2014. FIFTEEN (15) MINUTES OF DOWNTIME FOR AN UNSPECIFIED LABEL APPLIER ISSUE DURING LOT LRE73J WAS RECORDED IN THE DAILY OPERATION TRACKER, WHICH IS CONSISTENT WITH PRINT RIBBON REPLACEMENT.

    Description of Event or Problem · 1

    DURING INCOMING/LABELING OPERATION FOUND THE FOLLOWING DEFECT. DETAILS OF THE DEFECT IS UNREADABLE PRINTED LABEL (LOT# AND EXPIRATION DATE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324639 ENSEAL G2 CURVED JAW ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. L4E73J

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR