BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH* REUSABLE ENDOSCOPIC NEEDLE HOLDER

    MDR report key: 2500764 · Received March 22, 2012

    Report

    Report Number
    2210968-2012-00789
    Event Type
    Malfunction
    Date Received
    March 22, 2012
    Date of Event
    February 27, 2012
    Report Date
    February 28, 2012
    Manufacturer
    ETHICON INC.
    Product Code
    FHQ
    PMA / PMN Number
    K972694
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DEVICE WILL NOT RELEASE. THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ACTUAL SAMPLE WAS RETURNED FOR EVALUATION. IT WAS VISUALLY AND FUNCTIONALLY EXAMINED AND NO DEVIATIONS WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPY PROCEDURE ON (B)(6) 2012 AND AN ENDOSCOPIC NEEDLE HOLDER WAS USED. THE DEVICE DID NOT RELEASE PROPERLY, THE HANDLE DID NOT OPEN AND IT WAS STICKING. ANOTHER LIKE DEVICE WAS USED WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH* REUSABLE ENDOSCOPIC NEEDLE HOLDER MESH/ENDOS FHQ ETHICON INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1