BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3952928 · Received July 23, 2014

    Report

    Report Number
    3005075853-2014-05171
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? GASTRIC TISSUE ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? 2ND. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT?BLACK BEFORE THE EVENT. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? YES, SEAMGUARD. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? SOUNDED WEIRD DURING FIRING. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? MAYBE A LITTLE HIGHER FORCE DURING FIRING BUT NOT SURE. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? NOT SURE. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? THE MISFIRE WAS ON THE SPECIMEN SIDE. REP ALSO REPORTED THAT THERE WAS AN UPDATE TO THE EVENT THAT THE TWO ROWS OF STAPLES DID NOT FIRE ON THE SPECIMEN SIDE BUT DID FIRE ON PATIENT SIDE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BARIATRIC PROCEDURE, TWO ROWS OF STAPLES DID NOT FIRE ON THE PATIENT SIDE USING A GREEN CARTRIDGE. THE PATIENT IS OKAY. NO OTHER DETAILS ARE CURRENTLY KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429867 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4EL93

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - ECR60G