BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON*FLEX60

    MDR report key: 2222710 · Received August 25, 2011

    Report

    Report Number
    3005075853-2011-03492
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THORACOSCOPY PROCEDURE, AFTER SHOOTING THE MACHINE IN THE LUNG, THE SURGEON COULD NOT OPEN THE JAWS OF THE MACHINE. THE DEVICE WAS STUCK DESPITE THE EFFORTS OF THE SURGEON FOLLOWING THE SALES REP INSTRUCTIONS, WHO ARRIVED ON THE SCENE 15 MINUTES AFTER BEING CONTACTED. THE CONSEQUENCES THAT RESULTED WAS THE CONVERSION TO A THORACOTOMY SURGERY (THE PATIENT WAS OPEN) SO THAT THE SURGEON COULD MAKE THE RECESSION OF THE SURROUNDING LUNG TISSUE IN ORDER TO FREE THE MACHINE. GIVEN THIS SITUATION THE SURGEON WAS FORCED TO PERFORM ALMOST A TOTAL LUNG RECESSION FOR THE PATIENT. AS A RESULT OF THE DIFFICULTIES ENCOUNTERED WITH THIS DEVICE, THE PROCEDURE WAS PROLONGED 60 MINUTES. AFTER THE LIBERATION OF THE MACHINE, THE SALES REP MANAGE TO SUCCEEDED IN OPENING THE MACHINE IN HIS FOURTH ATTEMPT. THE CONDITION OF THE PATIENT IMMEDIATELY FOLLOWING THE EVENT WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THORACOSCOPY PROCEDURE, AFTER SHOOTING THE MACHINE IN THE LUNG, THE SURGEON COULD NOT OPEN THE JAWS OF THE MACHINE. THE DEVICE WAS STUCK DESPITE THE EFFORTS OF THE SURGEON FOLLOWING THE SALES REP INSTRUCTIONS, WHO ARRIVED ON THE SCENE 15 MINUTES AFTER BEING CONTACTED. THE CONSEQUENCES THAT RESULTED WAS THE CONVERSION TO A THORACOTOMY SURGERY (THE PATIENT WAS OPEN) SO THAT THE SURGEON COULD MAKE THE RECESSION OF THE SURROUNDING LUNG TISSUE IN ORDER TO FREE THE MACHINE. GIVEN THIS SITUATION THE SURGEON WAS FORCED TO PERFORM ALMOST A TOTAL LUNG RECESSION FOR THE PATIENT. AS A RESULT OF THE DIFFICULTIES ENCOUNTERED WITH THIS DEVICE, THE PROCEDURE WAS PROLONGED 60 MINUTES. AFTER THE LIBERATION OF THE MACHINE, THE SALES REP MANAGE TO SUCCEEDED IN OPENING THE MACHINE IN HIS FOURTH ATTEMPT. THE CONDITION OF THE PATIENT IMMEDIATELY FOLLOWING THE EVENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H43611

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention