BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLIP APPLIER - SMALL

    MDR report key: 2041867 · Received April 6, 2011

    Report

    Report Number
    3005075853-2011-01366
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 11, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). JAW. THE ANALYSIS RESULTS FOUND THAT DEVICE (A) WAS RECEIVED WITH THE JAWS MISALIGNED. A POSSIBLE CAUSE OF THIS CONDITION MAY BE THE INCORRECT/EXCESSIVE APPLICATION OF TORQUE TO THE JAWS DURING INSTRUMENT USE THAT CREATES A MISALIGNMENT OF THE TIPS WHICH MAY RESULT IN CLIP MALFORMATION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING OF THE DEVICE, THE INSTRUMENT LOADED, RETAINED AND DEPLOYED 6 CLIPS AS INTENDED. IN ORDER TO CONFIRM THE CLIPS WERE WITHIN MANUFACTURING SPECIFICATIONS, THE CLIPS WERE EVALUATED USING A TOOL THAT IS DESIGNED TO DETERMINE PROPER FORMATION. HOWEVER, THE FOUND CONDITION OF THE JAWS MAY LEAD CLIP MALFORMATION ISSUES. THE ANALYSIS RESULTS OF DEVICE (B) FOUND THAT IT WAS RECEIVED WITH THE JAWS MISALIGNED; THEREFORE THE CLIPS COULD NOT BE PROPERLY LOADED. A POSSIBLE CAUSE OF THIS CONDITION MAY BE THE INCORRECT/EXCESSIVE APPLICATION OF TORQUE TO THE JAWS DURING INSTRUMENT USE THAT CREATES A MISALIGNMENT OF THE TIPS WHICH MAY RESULT IN CLIP MALFORMATION. SERIAL # (B)(4); MFG DATE: 07/29/2010. JAW. THE ANALYSIS RESULTS FOUND THAT DEVICE (C) WAS RECEIVED WITH THE JAWS MISALIGNED. A POSSIBLE CAUSE OF THIS CONDITION MAY BE THE INCORRECT/EXCESSIVE APPLICATION OF TORQUE TO THE JAWS DURING INSTRUMENT USE THAT CREATES A MISALIGNMENT OF THE TIPS WHICH MAY RESULT IN CLIP MALFORMATION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING OF THE DEVICE, THE INSTRUMENT LOADED, RETAINED AND DEPLOYED 6 CLIPS AS INTENDED. IN ORDER TO CONFIRM THE CLIPS WERE WITHIN MANUFACTURING SPECIFICATIONS, THE CLIPS WERE EVALUATED USING A TOOL THAT IS DESIGNED TO DETERMINE PROPER FORMATION. HOWEVER, THE FOUND CONDITION OF THE JAWS MAY LEAD CLIP MALFORMATION ISSUES. SERIAL # (B)(4); MFG DATE: 01/20/2010. JAW. THE ANALYSIS RESULTS OF DEVICE (D) FOUND THAT IT WAS RECEIVED WITH THE JAWS MISALIGNED; THEREFORE THE CLIPS COULD NOT BE PROPERLY LOADED. A POSSIBLE CAUSE OF THIS CONDITION MAY BE THE INCORRECT/EXCESSIVE APPLICATION OF TORQUE TO THE JAWS DURING INSTRUMENT USE THAT CREATES A MISALIGNMENT OF THE TIPS WHICH MAY RESULT IN CLIP MALFORMATION. SERIAL # (B)(4); MFG DATE: 02/02/2009. JAW. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE, THE CLIP APPLIER JAWS WAS NOT HOLDING CLIPS PROPERLY, RESULTING IN IMPROPER CLOSURE OF CLIPS. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLIP APPLIER - SMALL CLIP APPLIER - SMALL GDO ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1