BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRALIGHT ST W/ ECHO 2

    MDR report key: 11663846 · Received April 14, 2021

    Report

    Report Number
    1213643-2021-20073
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    October 16, 2020
    Report Date
    March 26, 2021
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    UDI-DI
    00801741130984
    PMA / PMN Number
    K170294
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED, A BARD/DAVOL VENTRALIGHT ST W/ECHO 2 (DEVICE 2) WAS USED IN A IN A ROBOTIC UMBILICAL HERNIA REPAIR PROCEDURE. AS REPORTED DURING INSERTION THROUGH AN INTUITIVE SURGICAL 12MM STAPLER CANNULA SEAL 470380 (DEVICE 1), THERE WAS A DETACHMENT OF THE ECHO 2 POSITIONING SYSTEM FROM THE VENTRALIGHT ST IMPLANT. THE VENTRALIGHT ST ECHO 2 SAMPLE WAS NOT RETURNED FOR EVALUATION. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE TO THE FACILITY TO GATHER ADDITIONAL DETAILS, HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE INSTRUCTIONS-FOR-USE (IFU) SUPPLIED WITH DEVICE 1 STATES: "INSERT INTO THE ABDOMEN THROUGH THE RECOMMENDED MINIMUM TROCAR OR TROCAR INCISION SITE. NEVER FORCE THE DEVICE THROUGH THE TROCAR. IF THE DEVICE WILL NOT EASILY DEPLOY DOWN THE TROCAR, REMOVE THE TROCAR AND INSERT THROUGH THE NEXT LARGEST AVAILABLE SIZE TROCAR OR THROUGH THE TROCAR INCISION SITE AND REINSERT TROCAR." ADDITIONALLY, THE IFU RECOMMENDS THE USE OF A 10MM TROCAR SIZE FOR THE PRODUCT CODE USED. AT THIS TIME NO DEFINITIVE CONCLUSIONS CAN BE MADE AS TO WHY THE DETACHMENT PRESENTED. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. NOT RETURNED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED VIA FDA 3500A FORM REPORT ((B)(4)): "DAVOL INC. VENTRALIGHT ST MESH WITH ECHO 2 POSITIONING SYSTEM 10 CM X 15 CM (4" X 6") ELLIPSE WAS BEING INSERTED THROUGH A PORT WHEN PLASTIC PIECE BROKE OFF. THE VENTRALIGHT ST MESH HAS PLASTIC FRAME THAT WAS TOO RIGID/BIG TO FIT THROUGH PORT." THE PROCEDURE BEING PERFORMED WAS A ROBOTIC UMBILICAL HERNIA REPAIR. AS REPORTED DEVICE 1 INTUITIVE SURGICAL 12MM STAPLER CANNULA SEAL 470380. NO ALLEGED PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROBLEM EXPERIENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565367 VENTRALIGHT ST W/ ECHO 2 SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA NI 00801741130984

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other