BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 7307596 · Received March 1, 2018

    Report

    Report Number
    1219930-2018-01163
    Event Type
    Malfunction
    Date Received
    March 1, 2018
    Date of Event
    January 16, 2017
    Report Date
    March 1, 2018
    Manufacturer
    US SURGICAL (INACTIVE)
    Product Code
    GDW
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS PREVIOUSLY REPORTED TO THE FDA ON A SUMMARY REPORT AND IS NOW BEING SUBMITTED ON A 3500 A PER FDA REQUEST.¿ EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. ANALYSIS CONCLUDED THERE WERE NO ASSEMBLY COMPONENT RELATED FAILURES. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY AMENDED AS APPROPRIATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE ANVIL WAS DROP OUT OF THE RELOAD BEFORE TO USE. *WHEN WAS THE PROBLEM NOTICED: PRIOR TO USE PATIENT INVOLVEMENT? NO. PATIENT INJURY? NO. PATIENT INFORMATION: N/A. WHAT IS THE CURRENT CONDITION OF THE PATIENT? STABLE. MEDICAL INTERVENTION REQUIRED? NO. WAS SURGERY TIME EXTENDED BY 30MINS OR MORE? NO. WAS PRODUCT TESTED PRIOR TO USE? YES. UDI NUMBER: N/A. ADDITIONAL INFORMATION RECEIVED ON 1/23/2017. WHAT IS THE LOT NUMBER OF THE 030450 RELOAD? UNKNOWN. IF THE CUSTOMER CANNOT SUPPLY THE SPECIFIC LOT NUMBER, CAN THE CUSTOMER STATE WHAT LOT NUMBERS WERE IN INVENTORY AT THE TIME OF SURGERY? WHAT ARE THE POTENTIAL LOT NUMBERS? UNKNOWN. WHAT IS THE PRODUCT ID FOR THE HANDLE THAT WAS USED? UNKNOWN. IF THE CUSTOMER CANNOT REPORT THE PRODUCT ID, WAS IT A LEGACY UNIVERSAL (SUCH AS 030403, 030449, EGIAUNIVXL), WAS IT AN EGIA ULTRA (SUCH AS EGIAUSHORT, EGIAUSTND, EGIAUXL), WAS IT AN IDRIVE (IDRVULTRA1, IDRVULTRA2), OR SIGNIA (SIGPHANDLE)? EGIAUSTND. WHAT IS THE LOT NUMBER OF THE HANDLE? UNKNOWN. WHAT IS THE UDI NUMBER OF THE HANDLE? UNKNOWN. CAN YOU CONFIRM IF THE HANDLE WILL BE RETURNED FOR EVALUATION? NO. WAS THE HANDLE REPROCESSED OR RE-STERILIZED PRIOR TO USE? NO. THE HANDLE WAS SINGLE USE. WAS ANY REINFORCEMENT MATERIAL USED IN CONJUNCTION WITH THE STAPLING DEVICE? NO. IF YES, WHAT WAS THE BRAND OF THE REINFORCEMENT MATERIAL USED? WHAT WAS THE ITEM CODE AND LOT / SERIAL NUMBER OF THE REINFORCEMENT MATERIAL? CAN YOU PROVIDE ADDITIONAL DETAILS REGARDING THE INCIDENT? THE ANVIL WAS DROP OUT OF THE RELOAD BEFORE TO USE. DID ANY PART OF THE DEVICE FALL INTO THE CAVITY OF THE PATIENT? NO. IF YES, WHAT PART AND HOW WAS IT RETRIEVED FROM THE PATIENT? 6. WHAT WAS DONE TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE? CHANGED A NEW ONE. CAN YOU CONFIRM IF THE DEVICE WILL BE RETURNED FOR EVALUATION? YES. WAS THE DEVICE REPROCESSED OR RE-STERILIZED PRIOR TO USE? NO. THE DEVICE WAS SINGLE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149806 ENDO GIA STAPLE, IMPLANTABLE GDW US SURGICAL (INACTIVE) 030450 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1