BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 3103057 · Received May 9, 2013

    Report

    Report Number
    3005075853-2013-02207
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 15, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNED FOR ANALYSIS SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, THERE WAS A PACKAGING LOT OR BATCH NUMBER PROVIDED BY THE USER FACILITY. THE BATCH RECORDS WERE REVIEWED AND THE FINAL QUALITY RELEASE CRITERIA WERE MET BEFORE THE BATCHES WERE RELEASED FOR DISTRIBUTION. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? STOMACH AT WHAT LOCATION ON THE TISSUE? 2 CM PROXIMAL FROM THE PYLORUS. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? 1ST. ECHELON STRAIGHT/FLEX: ASKU. ECHELON POWERED 60MM ARTICULATED PLE60A. DURING WHICH STROKE DID THE EVENT OCCUR? POWERED GUN, THEREFORE ONE STROKE. WHAT COLOR CARTRIDGE WAS BEING USED? BLACK. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? AFTER BLACK RELOAD, HE USED 4 X GREEN RELOADS WITHOUT INCIDENT. WAS BUTTRESSING MATERIAL UTILIZED? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY UNEXPECTED NOISES 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. WAS THE TISSUE THICK? YES. HOW WAS THE PROCEDURE COMPLETE? ENTIRE STAPLE LINE WAS OVER SEWN AS PER HIS NORMAL PRACTICE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, FIRST FIRING TOWARDS THE DISTAL END OF THE RELOAD, THERE WERE ABOUT 4 X STAPLE DEFLECTIONS WHERE THE STAPLES DID NOT MAKE CONTACT WITH THE ANVIL. NO ADVERSE EVENT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203782 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK K4C600

    Patients

    Seq Age Sex Outcome Treatment
    1