BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT

    MDR report key: 1932731 · Received December 20, 2010

    Report

    Report Number
    3005075853-2010-07250
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 7, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). EXTERNAL CAUSE. THERE WAS ONE CARTON, BLISTER, AND TYVEK RECEIVED. THE PACKAGE WAS RECEIVED WITH THE END OF THE BLISTER CRACKED/BROKEN OFF. THERE WAS EVIDENCE OF SEAL TRANSFER ON THE ENTIRE CIRCUMFERENCE OF THE TYVEK LID, CONFIRMING THAT THE TYVEK HAD BEEN PROPERLY AND COMPLETELY SEALED TO AN UNDAMAGED BLISTER. THE INDIVIDUAL CARTON WAS EXAMINED FOR DAMAGE AND FOUND TO BE IN FAIR CONDITION, INDICATING THE BLISTER MOST LIKELY BECAME BROKEN WHILE OUTSIDE OF THE CARTON AND THEN PLACED BACK INTO THE CARTON. A LARGE BROKEN PIECE OF THE BLISTER WAS FOUND INSIDE THE CARTON, BUT SOME SMALL SHARDS OF THE BLISTER WERE NOT FOUND, FURTHER INDICATING THAT BLISTER WAS MOST LIKELY BROKEN OUTSIDE OF THE CARTON. EACH DEVICE IS PACKAGED IN A PRIMARY BLISTER PACK THAT IS PLACED INTO AN INDIVIDUAL CARTON, THEN PLACED INTO A CORRUGATED SALES UNIT, AND FINALLY INTO A CORRUGATED SHIPPER CARTON. EACH DEVICE/PACKAGING IS VISUALLY INSPECTED DURING THE PACKAGING PROCESS AND DAMAGE OF THIS MAGNITUDE WOULD MOST LIKELY HAVE BEEN DETECTED DURING OUR 100% VISUAL INSPECTION. DAMAGE OCCURRED OUTSIDE OF PACKAGING FACILITY AND WAS CAUSED BY DROPPING OR IMPACT TO THE PACKAGE. THERE WAS NO OTHER DAMAGE TO THE PACKAGE. ROOT CAUSE FOR DAMAGE IS MOST LIKELY DUE TO EXTERNAL HANDLING. BATCH HISTORY RECORDS WERE REVIEWED WITH NO PROTOCOLS, DEFECTS, NON-CONFORMANCES OR QUARANTINE NOTED. THE PRODUCT MET ALL IN-PROCESS AND FINISHED GOODS SPECIFICATIONS UPON RELEASE OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BUBBLE PACK WAS DAMAGED / CRACKED. THE STERILITY MAY HAVE BEEN COMPROMISED. THE DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE