BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1874306 · Received October 19, 2010

    Report

    Report Number
    3005075853-2010-05942
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 27, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    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 (B)(4) DEVICE FOUND THAT IT WAS RECEIVED WITH THE JAWS IN THE CLOSED POSITION. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS; HOWEVER, DIFFICULTIES WERE NOTED DUE THE ACCUMULATION OF EXCESSIVE DRIED BODY FLUIDS THAT CAUSED THE ONE CAM RAMP GOT BROKEN. ONE PEAR SHAPED CLIP WAS RELEASED. SEE ATTACHED PICTURES. ACCUMULATION OF BODY FLUIDS IS A ROUTINE OCCURRENCE DURING SURGICAL PROCEDURES AND DOES NOT NECESSARILY INDICATE A MANUFACTURING DEFECT IN THE DEVICE. NO TESTING COULD BE PERFORMED TO EVALUATE THE EVENT REPORTED DUE THE CONDITION OF THE DEVICE. HOWEVER, AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF THE REPORTED OPENING ISSUES. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED: "THE JAW BECAME NOT TO OPEN WITH THE TARGET TISSUE IN THE JAW. THE JAW WAS OPENED BY OPENING THE TRIGGER WITH HAND. AFTER THIS EVENT THE NURSE FIRED THE DEVICE OUTSIDE THE PATIENT'S BODY, THE CLOSING AND OPENING OF THE JAW WAS NOT SMOOTHLY." FURTHER DETAILS WERE REQUESTED AND THE FOLLOWING WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE, THE CLIP HAD DIFFICULTY IN COMING OUT AT THE SECOND FIRING. ALSO, THE JAW WOULD NO LONGER OPEN AND THE TRIGGER COULD NOT BE GRASPED PROPERLY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIP DID NOT COME OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. G4RG5M

    Patients

    Seq Age Sex Outcome Treatment
    1