BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 16889990 · Received May 8, 2023

    Report

    Report Number
    2955842-2023-12955
    Event Type
    Injury
    Date Received
    May 8, 2023
    Date of Event
    April 10, 2023
    Report Date
    April 11, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112496
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, IT IS UNKNOWN WHAT CAUSED THE TIP OF THE TIP-UP FENESTRATED GRASPER INSTRUMENT TO BREAK OFF INSIDE THE PATIENT AND IT HAS NOT BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. SYSTEM LOGS REVEALED NO RELATED SYSTEM ERROR OCCURRING DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE TIP OF THE TIP-UP FENESTRATED GRASPER BROKE OFF INSIDE THE PATIENT AND WAS NOT RETRIEVED AFTER LOOKING FOR 2 HOURS AND USING INTRAOPERATIVE CT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY PROCEDUR, THE TIP OF THE TIP-UP FENESTRATED GRASPER BROKE OFF AND FELL INSIDE THE PATIENT. AFTER LOOKING FOR 2 HOURS WITH INTRAOPERATIVE COMPUTED TOMOGRAPHY (CT), THE INSTRUMENT FRAGMENT WAS UNABLE TO BE LOCATED. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) HAS MADE MULTIPLE UNSUCCESSFUL FOLLOW-UP ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765042 ENDOWRIST TIP-UP FENESTRATED GRASPER NAY INTUITIVE SURGICAL, INC 470347-12 K10221016 0225 00886874112496

    Patients

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