BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1852449 · Received October 4, 2010

    Report

    Report Number
    3005075853-2010-05669
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 10, 2010
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). JAWS UNABLE TO OPEN_OPEN AFTER ASSISTED THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE EVENT REPORTED, THE DEVICE WAS TESTED FOR FUNCTIONALITY. IT WAS FIRED AND DUE TO THE ANTI BACKUP FEATURE BEING NON-FUNCTIONAL, TWO UNFORMED CLIPS WERE FED. POSSIBLE CAUSES FOR THIS CONDITION MAY BE ATTEMPTING TO SQUEEZE THE DEVICE TRIGGER WHEN IT HAS NOT FULLY RETURNED OR STOPPING THE FIRING SEQUENCE AND PULLING THE TRIGGER OPEN. THE REMAINING CLIPS WERE CONFORMING ACCORDING TO OUR MANUFACTURING SPECIFICATIONS; HOWEVER, DURING THE LAST TWO FIRING SEQUENCES, THE JAWS REMAINED IN THE CLOSED POSITION. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS WITHOUT ANY ANOMALIES NOTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH ULTRAMINI METER DISPLAYED AN "ER 1" MESSAGE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE REPORTER OR THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE. THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2010. THE CUSTOMER CARE ADVOCATE (CCA) WAS ADVISED THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN WHAT ACTION THE PATIENT TOOK AT THE TIME OF THE ALLEGED ISSUE. ABOUT HALF AN HOUR AFTER THE ALLEGED ISSUE BEGAN, THE REPORTER CLAIMED THE PATIENT FELT A SYMPTOM OF SHAKINESS. THE REPORTER DENIED THE PATIENT RECEIVED MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED IT WAS NOT THE FIRST TIME THE SUBJECT METER WAS BEING TESTED WITH. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. IT IS NOT KNOWN IF CHANGES WERE MADE TO THE PATIENT'S DIABETES REGIMEN OR IF SHE CONTINUED TO TEST HER BLOOD GLUCOSE ON ANOTHER DEVICE; HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE A REPORTER CLAIMED THE PATIENT WAS UNABLE TO TEST HER BLOOD GLUCOSE ON THE SUBJECT METER DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC NEPHRECTOMY PROCEDURE, THE DEVICE WAS USED FOR MULTIPLE FIRINGS ON THE RENAL PHYLUM. ON THE 11TH AND 13TH FIRINGS, THE JAWS REMAINED CLOSED ON THE VESSEL. THE SURGEON FORCED THE HANDLES OPEN AND THE JAWS OPENED. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT EXPERIENCED ONLY A VERY SMALL AMOUNT OF BLOOD LOSS. NO OTHER IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4TJ23

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR