BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE

    MDR report key: 5586795 · Received April 19, 2016

    Report

    Report Number
    2210968-2016-08297
    Event Type
    Malfunction
    Date Received
    April 19, 2016
    Date of Event
    March 30, 2016
    Report Date
    March 31, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    GDW
    PMA / PMN Number
    K093845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION CODE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION REVEALED THAT THE DEVICE POSITION AND PAPER FOLDER CONDITION INDICATES THAT THE DEVICE WAS MISHANDLED AT UNKNOWN POINT AND CANNULA IMPACTED THE FOLDER AND SEAL AREA, THEREFORE STERILE BARRIER WAS COMPROMISED AS A RESULT OF A SEVERE NON-NORMAL HANDLING AFTER IT WAS SHIPPED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROSCOPIC HERNIA REPAIR ON (B)(6) 2016 AND ABSORBABLE STRAPS WERE USED. IT WAS REPORTED THAT, PRIOR TO THE PROCEDURE, PART OF DEVICE WAS PROTRUDING OUT FROM THE HOLE. DURING THE EVALUATION, IT WAS FOUND AN OPEN OR COMPROMISED SEAL IN THE POUCH. THE OPEN SEAL WAS LOCATED ON CANNULA TIP SEAL AREA. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241609 SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE STAPLE, IMPLANTABLE GDW ETHICON INC. UNK JPM342

    Patients

    Seq Age Sex Outcome Treatment
    1