BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX45

    MDR report key: 3181855 · Received June 21, 2013

    Report

    Report Number
    3005075853-2013-03187
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? IT WAS THE THIRD OR FOURTH HOW MUCH TISSUE WAS RESECTED TO REMOVE THE DEVICE (SPECIFY IN CM)? THE DEVICE WAS RESECTED OUT AND APPROXIMATELY 1¿ X 2¿ PIECE OF TISSUE WAS REMOVED WITH THE DEVICE. DID THE DEVICE EVENTUALLY OPEN AFTER IT WAS REMOVED FROM THE TISSUE? YES, WE RECEIVED THE INSTRUCTIONS FOR USE FROM YOU GUYS AND AFTER THE PROCEDURE WE FOLLOWED THE STEPS AND THE JAWS OPENED. DURING WHICH STROKE DID THE EVENT OCCUR (WAS THE FIRING SEQUENCE COMPLETED AND THEN ATTEMPTED TO OPEN)? THE FIRING SEQUENCE WAS COMPLETED. WHAT COLOR CARTRIDGE WAS BEING USED? GOLD. IF BUTTRESSING MATERIAL WAS UTILIZED, WHICH PRODUCT WAS USED? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? YES, PART OF IT WOULD HAVE BEEN OVER-LAPPING A STAPLE LINE. PRIOR TO THE ATTEMPT TO OPEN, WERE ANY UNEXPECTED NOISES WERE HEARD, WHEN WERE THEY HEARD? NO, THE SURGEON WAS SURPRISED THAT JAWS DID NOT OPEN. PRIOR TO THE ATTEMPT TO OPEN, WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED INCLOSING OR FIRING? ASKU. HOW WAS THE CASE COMPLETED? A SECOND DEVICE WAS OPENED AND THE CASE WAS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. 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. WHAT IS THE LOT NUMBER FOR THE DEVICE? WHAT IS THE FIRST AND LAST NAME OF THE SURGEON WHO USED THE DEVICE? WHAT TYPE OF PROCEDURE WAS THE DEVICE USED IN? ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? HOW MUCH TISSUE WAS RESECTED TO REMOVE THE DEVICE (SPECIFY IN CM)? DID THE DEVICE EVENTUALLY OPEN AFTER IT WAS REMOVED FROM THE TISSUE? DURING WHICH STROKE DID THE EVENT OCCUR (WAS THE FIRING SEQUENCE COMPLETED AND THEN ATTEMPTED TO OPEN)? WHAT COLOR CARTRIDGE WAS BEING USED? IF BUTTRESSING MATERIAL WAS UTILIZED, WHICH PRODUCT WAS USED? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? PRIOR TO THE ATTEMPT TO OPEN, WERE ANY UNEXPECTED NOISES WERE HEARD, WHEN WERE THEY HEARD? PRIOR TO THE ATTEMPT TO OPEN, WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED INCLOSING OR FIRING? AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? HOW WAS THE CASE COMPLETED? WHAT IS THE CURRENT STATUS OF THE PATIENT? IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VATS PROCEDURE, THE DEVICE WAS "STUCK ON LUNG TISSUE." SURGEON COULD NOT RELEASE DEVICE FROM TISSUE. ANOTHER DEVICE WAS APPLIED AND THE TISSUE WAS REMOVED. NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282985 ECHELON*FLEX45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1