BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 4162127 · Received October 10, 2014

    Report

    Report Number
    3005075853-2014-06957
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 24, 2014
    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
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE, AN INVESTIGATION COULD NOT BE PERFORMED. WE DID NOT RECEIVE A BATCH NUMBER OR LOT NUMBER SO THEREFORE WE WERE UNABLE TO REVIEW THE MANUFACTURING RECORDS. WHAT WAS THE PATIENT¿S BMI AND GENDER? UNK. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? FIRST- THIRD FIRING. WHAT COLOR CARTRIDGE WAS BEING USED? GREEN. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? 2 GOLDS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, WHEN THE DEVICE IS ARTICULATED THE STAPLER IS FORCING THE ARTICULATION JOINT STRAIGHT AS IT IS MOVING DOWN THE CARTRIDGE, OCCURRING ON ALL DIFFERENT LOADS. THE CASE WAS FINISHED WITH A NEW STAPLER, SAME OCCURRENCE. STAPLER PULLING THE ARTICULATION JOINT STRAIGHT WHEN FIRING. STAPLE LINE WAS NOT COMPLETELY FORMED. THERE WAS NO BUTTRESSING USED. OVER SEWING WAS REQUIRED. TWO DEVICES WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644130 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60G, ECR60D