BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 45MM

    MDR report key: 3233980 · Received July 18, 2013

    Report

    Report Number
    3005075853-2013-03611
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 23, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? WHAT COLOR CARTRIDGE WAS BEING USED? WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? IF ANY UNEXPECTED NOISES WERE HEARD, WHEN WERE THEY HEARD? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE SURGEON WAS NOT ABLE TO GET THE DEVICE TO ADVANCE PAST THE FIRST 1/8 OF THE RELOAD. CASE COMPLETED WITH SAME DEVICE AND A NEW RELOAD. THERE WERE NO PATIENT CONSEQUENCES. DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333758 PWRD ECH FLEX 45MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1