BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMOINC ACE 23 CM

    MDR report key: 1112587 · Received August 11, 2008

    Report

    Report Number
    3005075853-2008-01111
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D4; H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ESOPHAGECTOMY PROCEDURE, THE ACTIVE BLADE BROKE AT THE BASE SUDDENLY AFTER USING ABOUT 30 MINS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMOINC ACE 23 CM LFL ETHICON ENDO-SURGERY, LLC NA E4KRQM

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR