BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS MED ACCESS RETRACTOR

    MDR report key: 3211804 · Received July 8, 2013

    Report

    Report Number
    3005075853-2013-03428
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K070198
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE IRIS SEAL OF THE HAP02 DEVICE WAS TORN. 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. THE IRIS SEAL EXHIBITED A TEAR. THE INITIATION SITE FOR THE TEAR WAS ADJACENT TO THE INNER UPPER SEAL RING AND PROPAGATED 360º AROUND THE UPPER RING. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: MULTIPLE REQUEST FOR RETURN OF DEVICE HAVE BEEN MADE BUT NO DEVICE HAS BEEN RETURNED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). TORN SEAL THE ANALYSIS RESULTS FOUND THAT THE IRIS SEAL OF THE HAP02 DEVICE (B) WAS TORN. 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. THE IRIS SEAL EXHIBITED A TEAR. THE INITIATION SITE FOR THE TEAR WAS ADJACENT TO THE INNER UPPER SEAL RING AND PROPAGATED 360º AROUND THE UPPER RING. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER COMPLAINED ABOUT THE RUPTURE OF THE MEMBRANE WITH RISK OF LEAKAGE OF MATERIAL IN ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309000 DEXTRUS MED ACCESS RETRACTOR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA K4C76W

    Patients

    Seq Age Sex Outcome Treatment
    1