BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20

    MDR report key: 670633 · Received January 31, 2006

    Report

    Report Number
    1527736-2006-00435
    Event Type
    Malfunction
    Date Received
    January 31, 2006
    Date of Event
    January 20, 2006
    Report Date
    January 24, 2006
    Manufacturer
    ETHICON ENDO-SURGERY, INC.(CINCINNATI)
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SENT: 03/22/2006. ADDITIONAL INFORMATION: D2, 4, 10; G4, 5; H2, 3, 4, 6. D4: INFORMATION WAS NOT PROVIDED BY USER FACILITY. EVALUATION SUMMARY: NO CONCLUSION COULD BE REACHED BASED ON THE ANALYSIS RESULTS AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE DEVICES (A,B) WERE RETURNED IN GOOD VISUAL CONDITION. THE DEVICES WERE CYCLED, FED, AND FORMED THE REMAINING CLIPS WITHIN MANUFACTURING REQUIREMENTS WHEN TESTED. THE DEVICES WERE FULLY FUNCTIONAL AND CONFORMING TO MANUFACTURING REQUIREMENTS. DEVICE B: BATCH#= A9AJ2J. MFG. DATE: 09/08/2005. EXP. DATE: 08/08/2010.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC COLECTOMY PROCEDURE, THE DEVICE JAMMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 FZP GDO ETHICON ENDO-SURGERY, INC.(CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN