BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 2931641 · Received January 28, 2013

    Report

    Report Number
    3005075853-2013-00343
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    November 2, 2012
    Report Date
    January 3, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: HOW WAS THE BLEEDING CONTROLLED? NA. HOW MUCH BLOOD LOSS? NO BLOOD LOSS. DID THE PATIENT REQUIRE A BLOOD TRANSFUSION? NO PATIENT IMPACT. HOW WAS THE PATIENT IMPACTED? NO IMPACT TO THE PATIENT. WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? UNKNOWN. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? ASKU. WHAT COLOR CARTRIDGE WAS BEING USED? GOLD LOADS. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? UNKNOWN. WAS BUTTRESSING MATERIAL UTILIZED? UNKNOWN. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? UNKNOWN. WERE ANY UNEXPECTED NOISES HEARD? UNKNOWN. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? UNKNOWN. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? YES. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? NO OTHER DETAILS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. DEVICE NOT RETURNED. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE BATCHES INCLUDED IN THIS LOT.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37052 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD-(B)(4)