BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE

    MDR report key: 4840548 · Received June 12, 2015

    Report

    Report Number
    2210968-2015-07013
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 18, 2015
    Report Date
    May 19, 2015
    Manufacturer
    ETHICON INC.
    Product Code
    GDW
    PMA / PMN Number
    K093845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: ACTUAL DEVICE WAS RETURNED FOR EVALUATION. VISUAL AND FUNCTIONAL INSPECTIONS WERE PERFORMED. THE DEVICE WAS RETURNED WITH THE CANNULA CAP DETACHED FROM THE CANNULA TABS AND MISSING.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE STRAPS WERE USED. DURING THE PROCEDURE, THE WHITE CANNULA CAP AT THE TIP FELL OFF INSIDE THE PATIENT. THE WHITE CAP WAS RETRIEVED FROM THE FIELD WITHOUT FURTHER TISSUE DISSECTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386254 SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE STAPLE, IMPLANTABLE GDW ETHICON INC. UNK JC5183

    Patients

    Seq Age Sex Outcome Treatment
    1