BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX-5MM

    MDR report key: 2103615 · Received May 26, 2011

    Report

    Report Number
    3005075853-2011-02130
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 12, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). DRIED FLUIDS, JAW. THE FOLLOWING INFORMATION WAS RECEIVED: THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED WITH ONE JAW BROKEN AT BIFURCATION MAKING THE INSTRUMENT NON-FUNCTIONAL. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS OF THE DEVICE, IT WAS DISASSEMBLED. UPON DISASSEMBLING, 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. IN ADDITION, DRIED BODY FLUIDS WERE NOTED THROUGHOUT THE INTERNAL COMPONENTS; THREE CLIPS ADHERED BY DRIED BODY FLUIDS ON THE CLIP TRACK WERE FOUND. ACCUMULATION OF BODY FLUIDS IS A ROUTINE OCCURRENCE DURING SURGICAL PROCEDURES AND DOES NOT NECESSARILY INDICATE A MANUFACTURING DEFECT IN THE DEVICE. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE, ONE OF THE BOWEL BLOOD VESSELS BEGAN TO BLEED. AFTER ATTEMPTS TO CONTROL THE BLEEDING WITH HARMONIC, IT DID NOT WORK AND THE SURGEON REQUESTED A CLIP APPLIER. A NEW ONE FROM THE ORIGINAL PACKAGE WAS HANDED TO HIM. THE SURGEON ATTEMPTED TO PLACE SEVERAL CLIPS FROM THE CLIP APPLIER WHEN AFTER THE THIRD CLIP THE DEVICE JAMMED. THE BLEEDING COULD NOT BE CONTROLLED AND SO THE SURGEON HAD TO CONVERT TO OPEN SURGERY. CO2 AND TROCARS WERE TAKEN OUT AND A 20-30 CM CUT WAS MADE TO ALLOW OPEN ACCESS TO THE SOURCE OF THE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4RG68

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention