BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILS 29MM, CURVED

    MDR report key: 10178589 · Received June 22, 2020

    Report

    Report Number
    3005075853-2020-03122
    Event Type
    Malfunction
    Date Received
    June 22, 2020
    Date of Event
    May 7, 2020
    Report Date
    May 10, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036003465
    PMA / PMN Number
    K983536
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH #: U5AP22. DEVICE ANALYSIS: THE ANALYSIS RESULTS FOUND THAT A CDH29A DEVICE WAS RETURNED OUTSIDE ITS ORIGINAL PACKAGE AND NO PACKAGING WAS RETURNED FOR ANALYSIS. DUE TO THE CONDITION OF NO PACKAGING RETURNED FOR ANALYSIS, NO VISUALLY INSPECTED COULD BE PERFORMED TO EVALUATE THE INCIDENT REPORTED. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSE THE REPORTED EVENT. EVENT COULD NOT BE CONFIRMED AS NO PACKAGING WAS RETURNED FOR ANALYSIS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS RECEIVED: REGARDING "ONE SIDE OF THE STERILE PACKAGING WAS DAMAGED", COULD YOU PLEASE PROVIDE MORE DETAILS? THERE IS ONE SMALL HOLE ON THE PLASTIC PACKAGING. WAS PART OF THE PACKAGING FOUND TO BE DAMAGED (TYVEK, PLASTIC/BLISTER, PACKAGING SEAL, ETC.)? PLASTIC. OR, WAS THERE DIFFICULTY OPENING THE PACKAGING MATERIAL (DIFFICULTY REMOVING/PEELING BACK THE TYVEK)? COULD YOU PLEASE IDENTIFY THE PACKAGING (PRIMARY PACKAGING, BOX, POUCH SEAL OR THE PLASTIC BAG)? PLASTIC BAG. COULD YOU PLEASE CLARIFY THE TYPE OF DAMAGE FOUND (BROKEN, PACKAGING WAS WORN, BENT, RAGGED, CONTAIN CUT OR SLIT, OR APPEAR RIPPED)? BROKEN. DID THE DAMAGE OF THE PRIMARY PACKAGING COMPROMISE THE STERILITY OF THE DEVICE? YES. PLEASE PROVIDE A PICTURE (IF AVAILABLE) - NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FIELD AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE RECTAL CANCER RESECTION SURGERY, BEFORE USED ON THE PATIENT, NOTED ONE SIDE OF THE STERILE PACKAGING WAS DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644555 ILS 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. CDH29A U4052V 10705036003465

    Patients

    Seq Age Sex Outcome Treatment
    1