BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 16668862 · Received April 3, 2023

    Report

    Report Number
    2955842-2023-11728
    Event Type
    Injury
    Date Received
    April 3, 2023
    Date of Event
    February 28, 2023
    Report Date
    March 8, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119815
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A FRAGMENT FELL INTO THE PATIENT, AN INVESTIGATION IS PENDING TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT, BUT FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED AFTER FAILURE ANALYSIS INVESTIGATION AND IF ADDITIONAL INFORMATION IS OBTAINED. THIS IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED DURING A DA VINCI-ASSISTED VENTRAL HERNIA TAPP SURGICAL PROCEDURE, A FRAGMENT FROM A MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED IN THE SAME PROCEDURE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP CABLE AT THE DISTAL END. COMMON CAUSES OF THE FAILURE MODE BROKEN - DISTAL INSTRUMENT GRIP CABLE ARE ATTRIBUTED TO A COMPONENT FAILURE. CABLE BREAKAGE, WHETHER PARTIAL OR FULL, MAY BE ATTRIBUTED TO REDUCTION IN ULTIMATE STRENGTH OF THE MATERIAL, WHICH MAY BE THE RESULT OF DAMAGE TO THE CABLE THROUGH EXTERNAL COLLISIONS, DURING USE, OR DURING REPROCESSING. THE COMPLAINT REGARDING THE MEGA SUTURECUT NEEDLE DRIVER ¿GOBBLE A NEEDLE AND THE CABLE SNAPPED, WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A DA VINCI-ASSISTED VENTRAL HERNIA TAPP SURGICAL PROCEDURE, CUSTOMER REPORTS A MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WAS INSTALLED, HAD ONE MORE USE, ¿GOBBLE A NEEDLE AND THE CABLE SNAPPED.¿ A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN INJURY REPORTED. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026951 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-15 K10220418 0111 00886874119815

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES