BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ALLPORT ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 1830351 · Received January 10, 2008

    Report

    Report Number
    1527736-2008-00203
    Event Type
    Malfunction
    Date Received
    January 10, 2008
    Report Date
    December 28, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    KOG
    PMA / PMN Number
    K934174
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE'S JAWS WOULD NOT OPEN PRIOR TO THE START OF THE CASE. THE CUSTOMER USED ANOTHER LIKE DEVICE TO START THE CASE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ALLPORT ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER KOG ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4HX7E

    Patients

    Seq Age Sex Outcome Treatment
    1