BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1882621 · Received October 26, 2010

    Report

    Report Number
    3005075853-2010-06074
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    September 24, 2010
    Report Date
    October 1, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). JAWS BROKEN. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED EMPTY WITH THE JAWS BROKEN AT BIFURCATION. THE MOST LIKELY REASON FOR JAW BIFURCATION BREAKAGE IS STRESS CORROSION CRACKING AND THE MOST LIKELY ROOT CAUSE IS EXPOSURE TO A SOLUTION CONTAINING CHLORINE. THIS CONDITION IS VERY UNLIKELY TO OCCUR DURING A SURGICAL PROCEDURE AND IS MOST LIKELY TO OCCUR AFTER POST-SURGERY DEVICE CLEANING. THE JAW BREAKAGE IS NOT OCCURRING AS A RESULT OF THE PRODUCT COMPLAINT DECONTAMINATION PROCESS. IN ADDITION, THE ORANGE INDICATOR WAS NOTED TO BE OVER TRAVELED. THESE FINDINGS ARE NOT RELATED WITH THE INCIDENT REPORTED. THE EVENT REPORTED COULD NOT BE CONFIRMED DUE TO THE RETURNED CONDITION OF THE DEVICE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT AN INCORRECT FUSE WAS INSTALLED IN THE CELL-DYN ANALYZER. THE CORRECT FUSE WILL BE SHIPPED TO THE CUSTOMER TO RESOLVE THE ISSUE. NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE FIRED MALFORMED CLIPS AND THEN LOCKED OUT AND WOULD NOT FIRE. NO OTHER INFORMATION WAS AVAILABLE AT THIS TIME. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1