BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1817432 · Received August 26, 2010

    Report

    Report Number
    3005075853-2010-04878
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 2, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANTI-BACKUP FAILURE, ORANGE INDICATOR OVER TRAVELED THE ANALYSIS RESULTS FOUND THAT THE (B)(4) DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED; HOWEVER, THE ANTIBACKUP FEATURE WAS NOTED TO BE NON-FUNCTIONAL. THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS VISIBLE AT 11TH FIRING SEQUENCE THUS, IT OVER TRAVELED. ALTHOUGH, NO OPENING ISSUES WERE NOTED DURING TESTING, AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE. 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. (B)(6).

    Description of Event or Problem · 1

    THE ABBOTT VP 2000 PROCESSOR IS A DEVICE DESIGNED TO AUTOMATE AND STANDARDIZE SLIDE SPECIMEN PROCESSING AND ROUTINE SLIDE STAINING FOR THE LABORATORY. CUSTOMER REPORTED HAVING A LEAKING BASIN AFTER RECEIVING THE PRODUCT RECALL NOTIFICATION FOR POTENTIAL VP 2000 PROCESSOR LEAKING BASINS. THE NOTIFICATION ASKED FROM CUSTOMERS TO TAKE THE FOLLOWING ACTION: "IF YOU NOTICE LEAKING OR WARPED BASINS OR AN INABILITY TO PLACE THE BASINS INTO THE VP 2000 PROCESSOR, PLEASE CALL YOUR LOCAL ABBOTT MOLECULAR REPRESENTATIVE FOR COORDINATION OF BASIN REPLACEMENT. AN ABBOTT MOLECULAR CUSTOMER SERVICE REPRESENTATIVE OR FIELD SERVICE REPRESENTATIVE WILL BE CALLING YOU TO COORDINATE REPLACEMENT OF YOUR VP 2000 HEATED REAGENT BASINS BEFORE DECEMBER 31, 2010. PLEASE NOTE THAT ADDITIONAL MEASURES HAVE BEEN TAKEN TO ENSURE CURRENTLY AVAILABLE INVENTORY DOES NOT EXHIBIT THIS ISSUE." ABBOTT MOLECULAR DISTRIBUTED AN URGENT PRODUCT RECALL (3005248192-06/18/2010-001-C) VIA (B)(4) TO (B)(6) CUSTOMERS BASED ON CUSTOMER RECEIPT OF VP 2000 PROCESSOR AND BASIN SPARE PART SINCE (B)(6) 2008. THE FOLLOWING MDRS WERE ALSO FILED: MDR 3005248192-2010-0002, FILED ON (B)(4). MDR 3005248192-2010-0005, FILED ON (B)(4). MDR 3005248192-2010-0006, (B)(4). MDR 3005248192-2010-0007, FILED ON (B)(4). NO INJURY WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC NEPHRECTOMY PROCEDURE, THE DEVICE HAD BEEN FIRED A FEW TIMES AND ONE TIME THE SURGEON HAD TO PUSH THE FIRING TRIGGER OPEN, THERE WAS NO TISSUE DAMAGE. WHILE FIRING ON THE RENAL ARTERY THE DEVICE WAS DIFFICULT TO FIRE AND THE INDICATOR WAS NOT IN THE ORANGE. A CLIP DEPLOYED AND THE JAWS WOULD NOT OPEN, THE SURGEON FORCED THE TRIGGER OPEN. THERE WAS NO TISSUE DAMAGE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    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