BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 3103209 · Received May 9, 2013

    Report

    Report Number
    3005075853-2013-02209
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. CARTRIDGE PAN DISLODGED. ADDITIONAL INFORMATION RECEIVED: SURGEON SAID THAT EVERYTHING WORKED FINE NOT SURE WHAT THE SCRUB TECH DID WITH THE CARTRIDGE. NOTHING ELSE TO REPORT. THE ANALYSIS RESULTS FOUND THAT ONE ECR45M UNFIRED AND OUT OF ITS ORIGINAL PACKAGE WAS RECEIVED. FURTHERMORE, THE CARTRIDGE PAN WAS NOTED TO BE DETACHED FROM THE CARTRIDGE. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE PAN BECAME DISLODGED FROM THE RELOAD, IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY, THE ENTIRE RELOAD FELL APART; THE SLED IS COMPLETELY DETACHED FROM THE LOAD HOUSING. IT IS UNKNOWN IF THIS WAS WHEN LOADING THE CARTRIDGE INTO THE DEVICE OR WHEN THE DEVICE WAS BEING FIRED. IT IS UNKNOWN KNOW HOW THE CASE WAS COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203561 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CK2L

    Patients

    Seq Age Sex Outcome Treatment
    1