BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON*FLEX60 COMPACT

    MDR report key: 2834086 · Received November 15, 2012

    Report

    Report Number
    3005075853-2012-05184
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 16, 2012
    Report Date
    November 2, 2012
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).DEVICE WAS NOT RETURNED FOR EVALUATION. WERE THERE ANY ANOMALIES NOTED DURING THE INITIAL PROCEDURE ON (B)(6)? ---THE FIRING FORCE WAS LOWER THAN EXPECTED. HOW LONG POSTOPERATIVELY DID THE PATIENT RETURN? ---WE HAVE NO DETAILED INFORMATION. WHAT WERE THE PATIENT SYMPTOMS? ---WE HAVE NO DETAILED INFORMATION. WAS THE A WEDGE OR SEGMENTAL LOBECTOMY? ---WE HAVE NO DETAILED INFORMATION. WAS A LEAK TEST PERFORMED DURING THE INITIAL OPERATION? ---YES. WATER LEAK TEST WAS PERFORMED. WAS THE SECOND PROCEDURE PERFORMED THORACOSCOPICALLY? --- SECOND PROCEDURE WAS NOT PERFORMED. HOW IS THE PATIENT CURRENTLY? ---THE PATIENT IMPROVED AND WAS DISCHARGED FROM THE HOSPITAL ON SCHEDULE. IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY? ---YES. WAS THE DEVICE DISCARDED AFTER THE INITIAL OPERATION? ---YES. PATIENTS PREEXISTING CONDITIONS? ---WE HAVE NO DETAILED INFORMATION. PATIENT AGE SEX AND WEIGHT? ---WE HAVE NO DETAILED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A LAP LOBECTOMY, AIR LEAKED WAS CONFIRMED WHEN X-RAY AND DRAIN WERE PERFORMED. A FIBRIN GLUE WAS USED THROUGH DRAIN TO STOP THE LEAK IN THE WARD. THE PATIENT IMPROVED AND WAS DISCHARGED FROM THE HOSPITAL ON SCHEDULE. RE-OPERATION WAS NOT PERFORMED, SO THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. WE HAVE NO INFORMATION ABOUT THE DATE OF TAKING X-RAY AND OF USING FIBRIN GLUE. DURING THE FORMER PROCEDURE ON (B)(6), THE DEVICE WAS FIRED ON THE LUNG TWICE FOR RESECTION. ANY UNEXPECTED NOISES WAS NOT HEARD WHEN THE DEVICE WAS FIRED. AS THE FIRING FORCE WAS LOWER THAN EXPECTED, THE TISSUE ON WHICH THE DEVICE WAS FIRED WAS PROBABLY THIN. BUTTRESSING MATERIAL WAS NOT UTILIZED. THERE WAS NOT ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE. THE STAPLES WERE FORMED AS INTENDED AND NO LEAK WAS CONFIRMED DURING WATER LEAK TEST. THOUGH IT COULD NOT BE DETERMINED, AS THERE WAS A POSSIBILITY THAT THE LEAK OCCURRED FROM THE STAPLE LINE, THIS EVENT WAS REPORTED. THE DEVICE WAS NOT USED AFTER THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ECR60D (DISCARDED)