BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOBRAFIX ENHANCED

    MDR report key: 3011037 · Received March 12, 2013

    Report

    Report Number
    1213643-2013-00089
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 19, 2013
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    GDW
    PMA / PMN Number
    K111153
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A TOTAL OF FIVE DEVICES AND ONE SEPRAMESH WERE RETURNED FOR EVAL. THE SEPRAMESH WAS RECEIVED WITH (B)(4) TACKS DEPLOYED INTO THE MESH AND SIX OUT OF THE (B)(4) FASTENERS WERE NOTED TO BE PROUD. IT CANNOT BE DETERMINED WHICH FASTENERS IN THE MESH WERE DEPLOYED FROM WHICH SORBAFIX DEVICE. A FUNCTION EVAL COULD NOT BE PERFORMED ON THE FIRST SORBAFIX DEVICE THAT WAS RETURNED, BECAUSE THE HANDLE WAS JAMMED AND THE UNIT WAS OUT OF SYNCHRONIZATION. THE DEVICE HANDLE COVER WAS REMOVED TO EXPOSE THE GEAR TRAIN AND INNER COMPONENTS. AN EVAL OF THE INNER COMPONENTS FOUND DAMAGE TO THE CLUTCH INPUT GEAR AND DRIED BLOOD WAS NOTED INSIDE THE HANDLE COVERS, GEARS AND INNER CANNULA. NINE FASTENERS REMAINED WITHIN THE DEVICE. BASED ON THE AVAILABLE INFO AND THE PRODUCT EVAL, WE ARE UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE AT THIS TIME. IT IS POSSIBLE THAT EXCESSIVE RESISTANCE CAUSED THE INNER COMPONENT DAMAGE DUE TO THE FORCES APPLIED TO THE DEVICE DURING USE. A REVIEW OF THE MFG RECORDS WAS PERFORMED AND THERE WAS NO EVIDENCE OF MFG RELATED CAUSE FOR THE REPORTED EVENT. THE IFU CAUTIONS TO AVOID EXCESSIVE TRIGGER FORCE AS THIS MAY DAMAGE THE DEVICE. SEE MDR 1213643-2013-00095 FOR INFO RELATED TO THE SECOND SORBAFIX USED ON (B)(6) 2013. SEE MDR 1213643-2013-00096 FOR INFO RELATED TO THE THIRD SORBAFIX USED ON (B)(6) 2013. SEE MDR 1213643-2013-00097 FOR INFO RELATED TO THE FOURTH SORBAFIX USED ON (B)(6) 2013. SEE MDR 1213643-2013-00098 FOR INFO RELATED TO THE FIFTH SORBAFIX USED ON (B)(6) /2013.

    Description of Event or Problem · 1

    INFO AS PROVIDED TO DAVOL: DURING A LAPAROSCOPIC HERNIA REPAIR THE SORBAFIX DEVICE WAS DEPLOYED FOUR TIMES, AFTER WHICH THE DEVICE THEN WOULD STICK AND WOULD NOT DEPLOY FASTENERS. A TOTAL OF FIVE SORBAFIX DEVICES WERE USED, EACH WAS REPORTED AS HAVING THE SAME ISSUES WITH JAMMING AND NOT DEPLOYING FASTENERS. AFTER SEVERAL ATTEMPTS TO FIXATE THE MESH (BARD SEPRAMESH,) THE MESH WAS REMOVED. THE SURGEON CHOSE TO CONVERTED FROM A LAPAROSCOPIC TO AN OPEN PROCEDURE TO FACILITATE COMPLETION OF THE CASE. THERE WAS NO REPORTED ADVERSE OUTCOME TO THE PT, ASIDE FROM HAVING TO CONVERT FROM A LAPAROSCOPIC TO AN OPEN PROCEDURE. DEVICE: 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104531 SOBRAFIX ENHANCED GDW DAVOL INC., SUB. C.R. BARD, INC. NA HUWK1620

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention