BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 2031440 · Received March 28, 2011

    Report

    Report Number
    3005075853-2011-01209
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE INSTRUMENT (A) WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE EJECTED THE REMAINING CLIPS. FINALLY, IT LOCKED OUT AS INTENDED. HOWEVER, IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE FOUND EJECTED CLIPS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS RESULTS FOUND THAT THE DEVICE (B) WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE EJECTED THE REMAINING CLIPS; NO MALFORMED CLIPS WERE NOTED. HOWEVER, THE LOCKOUT MECHANISM WAS FOUND TO BE NON-FUNCTIONAL. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE EJECTED CLIPS. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS OF THE DEVICE, IT WAS DISASSEMBLED. UPON DISASSEMBLING, THE LOCKOUT POSTS WERE FOUND TO BE BROKEN WHICH SUGGEST THAT A LOCKOUT PREMATURE OCCURRED. PLEASE NOTE THAT THESE CONDITIONS ARE UNRELATED WITH THE INCIDENT REPORTED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. DEVICE B ADDITIONAL INFORMATION: BATCH # F9GY96 EXPIRATION DATE: 06/2014 MANUFACTURING DATE: 07/2009 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIP WAS CONTINUOUSLY MISFIRED AND THE CLIP WAS BENT. 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 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1