BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE LINEAR STAPLER

    MDR report key: 4213461 · Received October 30, 2014

    Report

    Report Number
    3005075853-2014-07483
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 14, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WAS THE TRIGGER ADVANCED AND NO STAPLES WERE DEPLOYED? DID THE DEVICE LOCK OUT AND COULD NOT BE FIRED? WHAT TYPE OF PROCEDURE WAS THE DEVICE USED IN? HOW WAS THE CASE COMPLETED? WERE THERE ANY PATIENT CONSEQUENCES? IF YES, PLEASE EXPLAIN IN DETAIL.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS THE TRIGGER ADVANCED AND NO STAPLES WERE DEPLOYED? DID THE DEVICE LOCK OUT AND COULD NOT BE FIRED? WHAT TYPE OF PROCEDURE WAS THE DEVICE USED IN? HOW WAS THE CASE COMPLETED? WERE THERE ANY PATIENT CONSEQUENCES? IF YES, PLEASE EXPLAIN IN DETAIL. CUSTOMER DOES NOT RECALL WHAT HAPPENED EXACTLY, JUST THAT NO ADVERSE EVENT. THE ANALYSIS RESULTS SHOWED THAT THE TL60 DEVICE ARRIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED ON THE DEVICE. THE RELOAD WAS RETURNED VOID OF STAPLES. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT CYCLED, FIRED, AND ALL THE STAPLES FORMED AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE FAILED TO FIRE. NO OTHER INFORMATION REGARDING THE INCIDENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696216 PROXIMATE LINEAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4F187

    Patients

    Seq Age Sex Outcome Treatment
    1