BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 3871804 · Received June 13, 2014

    Report

    Report Number
    3005075853-2014-03972
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING INFORMATION HAS BEEN RECEIVED: ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? 5TH AND 6TH WHAT COLOR CARTRIDGE WAS BEING USED? GOLD WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? 4 BLUE CARTRIDGES WHAT WAS THE BMI OF THE PATIENT? APPROXIMATELY 50 WAS BUTTRESSING MATERIAL UTILIZED? SEAMGUARD 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 OR OPENING)? NO THE FOLLOWING INFORMATION WAS REQUESTED, BUT HAS NOT YET BEEN OBTAINED: PLEASE CLARIFY ON REOPERATION, WERE THE STAPLE OPEN (NOT FORMED) OR WERE THE STAPLES MISSING? CURRENT STATUS OF THE PATIENT?

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: BASED ON ADDITIONAL INFORMATION RECEIVED,THE MDR WAS UPDATED TO MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, TWO LOADS WERE FIRED WITH SEAMGUARD MATERIAL AND THE STAPLES DID NOT FORM CORRECTLY. THE CASE WAS COMPLETED BY OVERSEWING THE STAPLE LINE WITH SUTURE IN THE AFFECTED AREA. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ONE DEVICE WAS DISCARDED. THE SURGEON REPORTED ON (B)(6) THAT THE STAPLE LINES ACTUALLY LOOKED GOOD DURING THE CASE. THREE DAYS POSTOP, THE PATIENT PRESENTED AT THE ER AND WAS ADMITTED. DURING REOPERATION IT WAS DISCOVERED THAT THE SEAMGUARD WAS IN PIECES AND THE STAPLE LINES ON THE GOLD FIRINGS WERE WIDE OPEN. THE PATIENT IS STILL HOSPITALIZED.

    Description of Event or Problem · 1

    THERE WAS NO REOPERATION. DURING THE INITIAL PROCEDURE, THE SURGEON STATED THAT SOME OF THE STAPLES FORMED AND SOME WERE LEFT IN THE CARTRIDGE. SURGEON STATED THAT THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351019 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60B, ECR60D