BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS SEAL CAP ASSEMBLY

    MDR report key: 1822207 · Received December 3, 2007

    Report

    Report Number
    1527736-2007-08188
    Event Type
    Malfunction
    Date Received
    December 3, 2007
    Date of Event
    November 6, 2007
    Report Date
    November 9, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GCJ
    PMA / PMN Number
    K070198
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HAND ASSISTED LAP CHOLECYSTECTOMY PROCEDURE THE SURGEON HAD HIS HAND IN THE DEVICE AND THE SEAL CAP BROKE, HE USED A SECOND LIKE DEVICE TO COMPLETE THE DEVICE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS SEAL CAP ASSEMBLY GCJ ETHICON ENDO SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1