BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 45MM

    MDR report key: 3252029 · Received July 29, 2013

    Report

    Report Number
    3005075853-2013-03781
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 11, 2013
    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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? BLUE. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? YES. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? THIS WAS THE FIRST TIME THE SURGEON USED THE DEVICE THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER FURTHER INVESTIGATION IT WAS DETERMINED THE PRODUCT CODE INVOLVED IN THE EVENT WAS A PLE60A.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CYSTECTOMY PROCEDURE, ON THE FIRST FIRING WHILE DISSECTING THE BOWEL WITH A BLUE CARTRIDGE, ONE SIDE OF THE STAPLES DID NOT FORM CORRECTLY. THE RIGHT SIDE FORMED PERFECTLY FINE. ON THE LEFT SIDE, THE OUTER MOST TWO ROWS WERE FINE. THE ROW CLOSEST TO THE INSIDE WAS NOT FORMED. THE SURGEON OVER SEWED THE AREA. THE DEVICE WAS RELOADED WITH ANOTHER BLUE CARTRIDGE AND IT FIRED FINE. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT IMPACT TO THE PATIENT. THE DEVICE WAS DISCARDED .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353811 PWRD ECH FLEX 45MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR45B