BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2140729 · Received June 27, 2011

    Report

    Report Number
    3005075853-2011-02599
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 30, 2011
    Report Date
    June 1, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED WITH ONE JAW BROKEN AT BIFURCATION. EVIDENCES OF CORROSION ON THE BROKEN AREA WERE NOTED. 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. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE REPORTED INCIDENT. PLEASE NOTE THAT THIS CONDITION IS UNRELATED WITH THE INCIDENT REPORTED. 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 LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE, THE JAW COULD NOT BE OPENED IN CLAMPING THE TISSUE. ANOTHER CLIP WAS FIRED ON THE SIDE OF THE JAW, AND THEN THE JAW WAS OPENED BY RETURNING THE TRIGGER TO THE HOME POSITION BY HAND. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE DOCTOR COMMENTED THAT HE HAD NOT FIRED THE DEVICE 15 TIMES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1