BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21258481 · Received January 28, 2025

    Report

    Report Number
    2955842-2025-00916
    Event Type
    Malfunction
    Date Received
    January 28, 2025
    Date of Event
    December 23, 2024
    Report Date
    January 8, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119792
    PMA / PMN Number
    K214095
    Removal / Correction Number
    ISIFA2024-09-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS NOT CONFIRMED. FSE VISITED THE SITE AND CHECKED THE LOGS, HE CONFIRMED THAT THERE WERE LOGS SHOWING THE MASTER CONTROLLER BEING REMOVED FROM THE SURGEON'S HAND. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS NOT CONFIRMED BASED ON THE FIELD EVALUATION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT FOR EVALUATION. ISI RECEIVED A VIDEO CLIP RELATED TO THE ALLEGED COMPLAINT AND OBTAINED ADDITIONAL INFORMATION: THERE WAS INSERTION MOTION OF THE MARYLAND BIPOLAR INSTRUMENT AS WELL AS MOTION OF THE INSTRUMENT WRIST AFTER THE SURGEON TAKES CONTROL OF THE INSTRUMENTS. THIS MOTION DID NOT RESULT IN ANY VISIBLE INJURY. HOWEVER, THIS TYPE OF INSERTION MOTION CAN OCCUR IF THERE ARE ARM COLLISIONS OR OFF-SCREEN COLLISIONS WITH ANOTHER SURGICAL INSTRUMENT. THE INSERTION MOTION CAN ALSO OCCUR IF THE ARM CLUTCH BUTTON WAS DEPRESSED BY THE BEDSIDE ASSISTANT. THERE WAS ALSO A BRIEF "MATCH GRIPS" PROMPT ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) 3 ARM POD, WHICH OCCURRED WHEN AN ARM CLUTCH BUTTON WAS USED. ADDITIONALLY, THE INSTRUMENT WRIST MOTION CAN OCCUR IF THE INSTRUMENT RELEASE LEVERS ARE DEPRESSED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT MADE AN UNINTENDED MOVEMENT AND COLLIDED WITH THE CHEST WALL. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE REPORTED MOVEMENT ISSUE WAS AN INTERMITTENT PROBLEM, SPECIFICALLY AFTER HAPPENING ONCE IT HAD NOT REOCCURRED. THE DRAPE WAS BEING USED HAD BEEN DISCARDED; THE ISSUE WAS RESOLVED ON ITS OWN. THERE WAS NO INJURY TO THE PATIENT THAT HARMED THEIR HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550093 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-17 K12240111 0361 00886874119792

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES