BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 4813345 · Received June 2, 2015

    Report

    Report Number
    3005075853-2015-03307
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    April 8, 2015
    Report Date
    May 14, 2015
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WHAT TYPE OF PROCEDURE WAS THE DEVICE USED IN? WHAT TROUBLESHOOTING STEPS WERE ATTEMPTED TO OPEN THE DEVICE (SQUEEZING THE CLOSING TRIGGER WHILE SIMULTANEOUSLY DEPRESSING THE ANVIL RELEASE BUTTON, RED KNIFE REVERSE SWITCH)? DID THE JAWS OF THE DEVICE EVENTUALLY OPEN? WAS THERE ANY PATIENT CONSEQUENCE AS A RESULT OF THE PROCEDURE BEING PROLONGED? WAS THERE ANY CHANGE IN THE POST-OPERATIVE CARE OF THE PATIENT AS A RESULT OF THE EVENT?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT AN UNKNOWN TIME DURING AN UNKNOWN PROCEDURE, AFTER THEY HAD LET THE DEVICE PASS FROM THE TROCAR, THE TERMINAL BRANCHES DID NOT OPEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE PROLONGED, MINUTES UNKNOWN. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354000 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1