BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA ADAPTER XL

    MDR report key: 4140136 · Received October 3, 2014

    Report

    Report Number
    1219930-2014-00912
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 9, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GAG
    PMA / PMN Number
    K133762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: SLEEVE GASTRECTOMY ACCORDING TO THE REPORTER: SAME PRODUCT, SAME ISSUE, SAME ACCOUNT, DIFFERENT SERIAL NUMBERS. CUSTOMER WANTS TO RETURN REMAINING PRODUCT FOR CREDIT DUE TO IDENTICAL ISSUES WITH 4 OTHER ADAPTERS. PATIENT DISCHARGED; NO COMPLICATIONS. STAPLER SLOWED AND STOPPED IN TISSUE THAT IT WAS INDICATED FOR. THE DEVICE SEEMS TO HAVE LOST POWER SINCE THE BEGINNING OF ITS LIFE. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO UNANTICIPATED TISSUE DAMAGE. THERE WAS NO UNANTICIPATED EXTENSION FOR THE INCISION MORE THAN ONE INCH. THERE WAS NO UNANTICIPATED BLOOD LOSS OF MORE THAN 500CC. THERE WAS NO DELAY OVER 30 MINUTES. NO DEVICE FRAGMENT FELL IN THE PATIENT CAVITY. NO DEVICE FRAGMENT WAS LEFT IN THE PATIENT.*** ADDITIONAL INFORMATION REQUESTED VIA EMAIL 1. PLEASE CONFIRM THAT PRODUCT WILL BE RETURNED FOR INVESTIGATION. 2. CAN YOU DESCRIBE THE PRODUCT PROBLEM IN GREATER DETAIL? 3. DID THE INSTRUMENT PARTIALLY FIRE? A) IF SO, WAS THE STAPLE LINE INCOMPLETE? A) IF SO, HOW WAS THE STAPLE LINE COMPLETE (OVER SEWED, RESECTED + RE-STAPLED, CONVERSION TO OPEN PROCEDURE, ETC)? 4. DID THE INSTRUMENT LOCK ON TISSUE? A) IF SO, HOW WAS THE INSTRUMENT REMOVED FROM TISSUE (CUT OFF, PRIED OFF WITH AN ADDITIONAL TOOL, THEY WERE ABLE TO WORK IT OFF THE TISSUE, ETC)? 5. DO YOU KNOW THE LOT NUMBERS OF THE EGIATRS60AMT USED IN ANY OF THE CASES? 6. TO CONFIRM, THESE WERE ALL SEPARATE CASES? 7. TO CONFIRM, ALL THE CASES WERE PERFORMED ON SEPTEMBER 2, IF NOT, PLEASE UPDATE THE CORRESPONDING FTR WITH THE CORRECT DATE. 8. DO YOU KNOW THE PATIENT, WEIGHT, AND GENDER FOR ANY OF THE CASES? 9. DO YOU KNOW THE LAST KNOWN PATIENT STATUS FOR THE ANY OF THE CASES?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619882 ENDO GIA ADAPTER XL REUSEABLE SURGICAL STAPLER GAG COVIDIEN, FORMERLY US SURGICAL A DIVISON EGIAADAPTXL N4F0029UX

    Patients

    Seq Age Sex Outcome Treatment
    1 EGIATRS60AMT,