BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2041224 · Received April 6, 2011

    Report

    Report Number
    3005075853-2011-01357
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 11, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EXTERNAL CAUSE. CUSTOMER REPORTED HOLE IN TYVEK BEFORE PROCEDURE. ONE SEALED PACKAGE WITH INSTRUMENT WAS RECEIVED FOR ANALYSIS. NO CARTON WAS RECEIVED. PACKAGE WAS VISUALLY INSPECTED FOR DAMAGE AND A RIP IN THE TYVEK WAS NOTED IN THE TYVEK. RIP IS FORMED FROM THE OUTSIDE AND APPEARS TO HAVE BEEN CAUSED BY IMPACT AND COMPRESSION AGAINST THE TYVEK. THE SURFACE OF THE PACKAGE IS INDENTED AND PRESSED DOWN AS THOUGH A HEAVY OBJECT HAD BEEN ON TOP OF IT. THE BLISTER IS NOT DAMAGED, BUT DOES HAVE SOME WARPING THAT INDICATES THAT WEIGHT WAS UNEVENLY PLACED ON IT. BATCH HISTORY REVIEW INDICATES NO NONFORMANCES OR DEFECTS OCCURRED DURING PACKAGING PROCESS AND THERE WAS NO REWORK OR HANDLING OUTSIDE THE NORMAL PROCESS. ALL PACKAGES ARE 100% INSPECTED PRIOR TO PLACEMENT IN CARTONS. PACKAGES ARE UNABLE TO SHIFT POSITION WITHIN SALES UNIT CARTONS AND ARE NOT EXCESSIVELY LOOSE OR SNUG. SALES UNIT CARTONS ARE PLACED INTO CORRUGATE CONTAINERS FOR SHIPPING. THIS INDICATES THAT PACKAGE WAS MOST LIKELY NOT IN SALES UNIT CARTON WHEN DAMAGE OCCURRED. RIP IN TYVEK LID WAS CAUSED EXTERNAL TO PACKAGING PROCESS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE AN UNKNOWN PROCEDURE, THERE WAS A HOLE IN THE TYVEK. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1