BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 3113548 · Received May 15, 2013

    Report

    Report Number
    3005075853-2013-02341
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 20, 2013
    Report Date
    April 22, 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
    IN
    Reporter Occupation
    OTHER

    Narratives

    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. AS THE LOT NUMBER PROVIDED WAS FOUND TO BE INVALID, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION REQUESTED AND RECEIVED: WHERE WAS THE LOCATION OF THE MALFORMED STAPLES DISTAL, PROXIMAL OR IN THE MIDDLE OF THE STAPLE LINE?-MIDDLE. WERE THE MALFORMED STAPLES ON THE LINE CLOSEST TO THE CUT LINE OR IN ALL OF THE ROWS?-CLOSEST TO CUTLINE. WERE THE STAPLE LEGS UNFORMED OR DID THEY HAVE IRREGULAR SHAPES?-IRREGULAR SHAPE. HOW MUCH BLOOD WAS LOSS (SPECIFY IN MLS OR CCS)? DID THE PATIENT REQUIRE A BLOOD TRANSFUSION?-NO. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)?-2ND. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT?-GREEN. IF BUTTRESSING MATERIAL WAS UTILIZED, WHICH PRODUCT WAS USED?-NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP?-NO. IF ANY UNEXPECTED NOISES WERE HEARD, WHEN WERE THEY HEARD?-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. HOW WAS THE CASE COMPLETED?- BY SUTURING. WHAT IS THE CURRENT STATUS OF THE PATIENT?- DISCHARGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE THERE WAS STAPLE LINE OOZING AND MALFORMED STAPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215545 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1