BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ENDO LINEAR CUTTERS

    MDR report key: 6141258 · Received December 2, 2016

    Report

    Report Number
    3005075853-2016-06773
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    September 4, 2016
    Report Date
    September 4, 2016
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # N54V70. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. CAN YOU PLEASE CLARIFY THAT WHEN THE "STAPLE KNIFE STOPPED ON MIED OF STAPLE LINE WHEN SURGEON WAS FIRING"? DID THE SAFETY LOCKOUT ENGAGE (NO STAPLES OR A CUT LINE DELIVERED BEYOND THE LOCKOUT)? IF NOT, WERE THE STAPLE LINE AND CUT LINE APPROXIMATELY EQUAL IN LENGTH (DEVICE PARTIALLY FIRED AND STOPPED)? THE ANALYSIS RESULTS THAT ONE PSEE60A DEVICE WAS RETURNED WITH NO VISUAL NON-CONFORMANCES AND WITH A GST60G CARTRIDGE RELOAD NOT LOADED ON THE DEVICE. THE CARTRIDGE RELOAD WAS RECEIVED FULLY FIRED WITH THE PAN DISLODGED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD. THE DEVICE FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. NO CONCLUSION COULD BE REACHED ON WHAT MAY HAVE CAUSED THE CARTRIDGE PAN TO DISLODGE. ONE POSSIBLE CAUSE COULD BE IMPROPER UNLOADING TECHNIQUE. PLEASE MAKE SURE THE DEVICE IS UNLOADED BY PUSHING THE CARTRIDGE UPWARD (TOWARD THE ANVIL) TO UNSNAP THE RELOAD FROM THE CARTRIDGE JAW. ANY TWISTING OR OFF CENTER PUSHING CAN LEAD TO THIS ISSUE. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS. THE BATCH HISTORY RECORD WAS REVIEWED AND NO PROTOCOLS OR NCR RELATED TO THE COMPLAINT WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAPLE KNIFE STOPPED ON "MIED" OF STAPLE LINE WHEN SURGEON WAS FIRING THE DEVICE. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794180 PWRD ENDO LINEAR CUTTERS STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - GST60G