BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX ENDO CLIP APPLIER

    MDR report key: 5481577 · Received March 4, 2016

    Report

    Report Number
    3005075853-2016-01315
    Event Type
    Injury
    Date Received
    March 4, 2016
    Report Date
    February 24, 2016
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)46) INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # = N90264. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT WAS THE PROCEDURE: LAP CHOLE. WHAT WAS THE REASON FOR THE SURGERY: GALLBLADDER REMOVAL. EXPLAIN ISSUE WITH THE CLIP APPLIER: NOTHING . HOW LONG AFTER SURGERY WAS THE LEAK IDENTIFIED: ONE DAY POST OP, PATIENT CAME IN WITH BLOOD IN THE ABDOMEN . WHAT WAS REASON FOR THE RE-OP: IDENTIFIED THAT THE CLIP THAT WAS APPLIED TO THE CYSTIC ARTERY, WAS NO LONGER PRESENT. WHAT WAS DONE IN THE PROCEDURE TO ADDRESS THE LEAK: UNKNOWN . WHAT IS THE CURRENT PATIENT STATUS: NO PATIENT ISSUES AT THIS TIME. WAS THE CLIP LOADED ON STRUCTURE OR OFF STRUCTURE: OFF STRUCTURE. THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE INSTRUMENT WAS TESTED FOR FUNCTIONALITY. DURING THE ANALYSIS, THE DEVICE WAS CYCLED AND IT FED AND FORMED THIRTEEN CONFORMING CLIPS. UPON TESTING, THE JAWS OPEN AND CLOSE WITHOUT ANY DIFFICULTIES. IN ADDITION THE DEVICE LOCKED OUT AS INTENDED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WAS "AN ISSUE WITH THE CLIP APPLIER". THE CASE WAS COMPLETED USING ANOTHER DEVICE OF THE SAME PRODUCT CODE. THE PATIENT WAS READMITTED WITH A BLEED IN THE ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138449 LIGAMAX ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1