BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOLOOP* LIGATURE

    MDR report key: 3071489 · Received April 22, 2013

    Report

    Report Number
    2210968-2013-04256
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    April 5, 2013
    Manufacturer
    ETHICON, INC
    Product Code
    GAN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PROCEDURE WAS A VATS ESOPHAGECTOMY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE EVALUATION FOUND A CRACKED MECANYL TUBE WITH AN OPEN LOOP. VISUAL INSPECTION OF THE KNOT SHOWS THAT IT WAS CONFIGURED CORRECTLY. THE SUTURE BROKE AT THE BREAKPOINT OF THE MECANYL TUBE. A STRONG SQUEEZING MARK WAS DETECTED AT THE END OF THE SUTURE. IT WAS SEEMINGLY CAUSED DUE TO STRONG ATTACHMENT OF THE THREAD WITH THE MECANYL TUBE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN THE CANNULA WAS BROKEN THE LIGATURE BROKE AT THE BREAK POINT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171745 ENDOLOOP* LIGATURE MESH/ENDOS GAN ETHICON, INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1