BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 17376227 · Received July 24, 2023

    Report

    Report Number
    2955842-2023-17238
    Event Type
    Malfunction
    Date Received
    July 24, 2023
    Date of Event
    April 3, 2023
    Report Date
    June 23, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112342
    PMA / PMN Number
    K150284
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEGA NEEDLE DRIVER (MND) INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN MAIN TUBE. PIECES MEASURING PROXIMATELY 0.106¿ X 0.071¿ AND 0.239" X 0.146¿ WERE NOT RETURNED WITH THE INSTRUMENT. THE COMPLAINT REGARDING THE REPORTED ISSUE WAS CONFIRMED BY FAILURE ANALYSIS. REVIEW OF THE PROVIDED IMAGE OF THE MEGA NEEDLE DRIVER INSTRUMENT IDENTIFIED A MISALIGNED SHAFT AND WRIST. THE PROVIDED IMAGE WAS CONSISTENT WITH THE ALLEGED CUSTOMER COMPLAINT. REVIEW OF THE VIDEO CLIP WAS CONDUCTED BY THE CLINICAL DEVELOPMENT ENGINEER (CDE). THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THERE WAS A DAMAGE TO THE DISTAL PART OF SHAFT ON THE MEGA NEEDLE DRIVER INSTRUMENT AFTER A COLLISION. THE CAUSE OF THE DAMAGE WAS LIKELY BECAUSE OF THE COLLISION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SACROCOLPOPEXY SURGICAL PROCEDURE, THE TIP WAS DISLODGED FROM THE MAIN TUBE OF THE MEGA NEEDLE DRIVER (MND) INSTRUMENT. THE SURGEON STATED THAT THE MND INSTRUMENT WAS USED PROPERLY DURING THE PROCEDURE. THE CUSTOMER USED A BACKUP INSTRUMENT TO CONTINUE WITH THE PROCEDURE WHICH WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO FRAGMENT FALLING INTO THE PATIENT. THE PATIENT DID NOT RETURN TO THE HOSPITAL FOR ANY POST-SURGICAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233936 ENDOWRIST MEGA NEEDLE DRIVER NAY INTUITIVE SURGICAL, INC 470194-06 K11221009 0087 00886874112342

    Patients

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