BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRALIGHT ST W/ ECHO 2

    MDR report key: 15641830 · Received October 20, 2022

    Report

    Report Number
    1213643-2022-00664
    Event Type
    Malfunction
    Date Received
    October 20, 2022
    Date of Event
    September 28, 2022
    Report Date
    October 4, 2022
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    UDI-DI
    00801741130977
    PMA / PMN Number
    K170294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, FOLLOWING FIXATION THE SURGEON REMOVED THE ECHO 2 POSITIONING SYSTEM THROUGH A 5MM TROCAR. THE INSTRUCTIONS-FOR-USE (IFU), SUPPLIED WITH THE DEVICE RECOMMENDS THE USE OF A 10MM TROCAR FOR THE PRODUCT CODE (5990011) USED. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION PROVIDED AND WITHOUT HAVING THE SAMPLE TO EVALUATE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. HOWEVER, THE MOST POSSIBLE ROOT CAUSE IS THAT THE ISSUE PRESENTED DUE TO THE USE OF THE 5MM TROCAR WHICH IS SMALLER THAN THE RECOMMENDED SIZE PER THE IFU. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION, WITH NO INDICATION OF A MANUFACTURING RELATED CAUSE FOR THE EVENT REPORTED. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF (B)(4) UNITS RELEASED FOR DISTRIBUTION IN (B)(6) 2022. NOT RETURNED.

    Description of Event or Problem · 0

    AS REPORTED, DURING LAPAROSCOPIC UMBILICAL HERNIA REPAIR PROCEDURE ON (B)(6) 2022, THE SURGEON USED THE VENTRALIGHT ST W/ECHO 2 DEVICE. IT WAS REPORTED THAT DURING THE PROCEDURE ONE 12MM PORT (FOR MESH INSERTION) AND TWO 5MM PORTS (FOR SCOPE AND FIXATION DEVICE) WERE USED. AS REPORTED, AFTER INSERTING THE MESH, THE 12MM PORT WAS REMOVED. ONCE THE MESH WAS TACKED INTO PLACE, THE SURGEON GRABBED THE THINNEST END OF THE ECHO 2 POSITIONING SYSTEM WITH A GRASPER, LINING UP THE WIRE WITH THE GRASPER AND REMOVED IT THROUGH THE 5MM PORT. AS REPORTED WHILE REMOVING THE ECHO 2 POSITIONING SYSTEM THROUGH THE 5MM PORT THE WHITE COVER (FRAME) AROUND THE WIRE TORE INTO TWO PIECES AND THE ENTIRE WIRE COME OUT OF THE FRAME. THE SURGEON VERIFIED THAT ALL PIECES WERE ACCOUNTED FOR. THERE WAS NO PATIENT INJURY AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2821367 VENTRALIGHT ST W/ ECHO 2 SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUGS2054 00801741130977

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other