BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH 10MM BABCOCK W/HANDLE

    MDR report key: 1121893 · Received August 13, 2008

    Report

    Report Number
    3005075853-2008-01159
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 23, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    MDM
    PMA / PMN Number
    EXEMPTK91083
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 08/13/2008. DAMAGED SHAFT, OPEN HANDLE SEAM. EVAL SUMMARY: THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RETURNED BROKEN AT THE PROXIMAL END. ADDITIONALLY THE HANDLES WERE FOUND TO BE SEPARATED AT THE THUMB RING AREA. THE GRASPING FEATURE COULD NOT BE EVALUATED DUE TO THE RETURNED CONDITION. NO CONCLUSION COULD BE REACHED BASED ON THE ANALYSIS RESULTS AS TO WHAT MAY HAVE CAUSED THE DAMAGE FOUND. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP ROUX-EN-Y PROCEDURE, THE DEVICE WOULD NOT GRAB THE TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH 10MM BABCOCK W/HANDLE MDM ETHICON ENDO-SURGERY, LLC NA E4L214

    Patients

    Seq Age Sex Outcome Treatment
    1