BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH** DEXTRUS*

    MDR report key: 2950121 · Received February 8, 2013

    Report

    Report Number
    3005075853-2013-00536
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 17, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K070198
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE IRIS SEAL OF THE DEVICE WAS TORN. THE TORN PROPAGATED SO IT CREATED A HOLE ABOUT 1 CM IN LENGTH. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. HOWEVER, IT SHOULD BE NOTED THAT WITH THE IRIS SEAL TORN, THE OPENING AND CLOSING MECHANISM FUNCTIONED AS INTENDED. HOWEVER, IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THIS CONDITION. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    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. HOW WAS THE SOURCE OF THE AIR LEAK LOCATED? WHERE WAS THE LEAKING COMING FROM? WAS THERE ANY TROUBLESHOOTING DONE TO ADDRESS THE LEAKING? WHAT WAS THE APPROXIMATE SIZE OF THE INCISION? PLEASE CONFIRM THAT CRACKED IS THE SAME AS TORN? DID IT TEAR UPON DEVICE INSERTION? IF SO, WHAT INSTRUMENT WAS PLACED THROUGH THE HAP02? OR WAS THE AIR LEAKING PRIOR TO USE? WAS ANOTHER DEVICE NOT AVAILABLE FOR USE? WAS THE PROCEDURE CONVERTED TO OPEN B/C A SECOND DEVICE WAS NOT AVAILABLE? WERE THERE ANY OTHER FACTORS THAT LED TO THE CONVERSION? WHAT IS THE PATIENT'S CURRENT STATUS? IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY? HOW LONG HAS THE USER BEEN USING THE DEVICE?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RADICAL RESECTION OF ESOPHAGEAL CARCINOMA THE SURGEON PLACED THE DEVICE AND ESTABLISHED PNEUMOPERITONEUM FOUND THAT AIR LEAKED. THE FILM OF THE DEVICE WAS CRACKED. THE SURGEON HAD TO CHANGE TO OPEN SURGERY TO COMPLETE THE PROCEDURE. NOW THE PATIENT IS FINE. CONVERTED TO OPEN TO COMPLETE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54905 ENDOPATH** DEXTRUS* LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA CE0123

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention