BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH* REUSABLE ENDOSCOPIC NEEDLE HOLDER

    MDR report key: 2103115 · Received May 25, 2011

    Report

    Report Number
    2210968-2011-00682
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 6, 2011
    Manufacturer
    ETHICON
    Product Code
    GDF
    PMA / PMN Number
    K972694
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2011 AND AN ENDOSCOPIC NEEDLE HOLDER WAS USED. DURING THE PROCEDURE, THE NEEDLE HOLDER WOULD NOT RELEASE WHEN CLAMPED DOWN ON SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH* REUSABLE ENDOSCOPIC NEEDLE HOLDER NEEDLE HOLDER GDF ETHICON NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1