BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 17481148 · Received August 8, 2023

    Report

    Report Number
    2955842-2023-17574
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    June 28, 2023
    Report Date
    July 11, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112298
    PMA / PMN Number
    K220023
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT NOTING NON INTUITIVE MOTION, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA HAS BEEN ISSUED REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE SYSTEM HAD RECOGNITION ISSUE FOR DIFFERENT INSTRUMENTS ON ARM 1. THE LAST TWO INSTRUMENTS INSTALLED WORK FINE. THE SITE TRIED TO RESEAT THE STERILE ADAPTER (SA) AND 4 INSTRUMENTS WERE INSTALLED ON THIS ARM PRIOR WITH NO ISSUES. THE MONOPOLAR CURVED SCISSORS INSTRUMENT DID NOT RESPOND TO THE SURGEON'S COMMAND (DID NOT CUT AND ROTATED DIFFERENTLY FROM WHAT WAS REQUESTED). AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOUND MULTIPLE ERRORS 22020 IN THE LOGS. THE TSE ASKED TO SWAP SA FROM ANOTHER ARM AFTER THE SURGERY AND TO INSTALL AND DRIVE ALL INSTRUMENT AVAILABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER CONTACTED AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE MONOPOLAR CURVED SCISSORS INSTRUMENT DID NOT RESPOND TO THE SURGEON'S COMMAND (DIDN'T CUT AND ROTATED DIFFERENTLY FROM WHAT WAS REQUESTED) AND CAUTERY HOOK INSTRUMENT DID NOT RESPOND TO THE SURGEON'S REQUEST (SEEMED TO BE BROKEN AFTER REMOVAL FROM ARM. THE INSTRUMENT HAD NOISE INSIDE THAT WAS NOT PRESENT AT THE PREOPERATIVE EQUIPMENT CHECK. ANOTHER CAUTERY HOOK INSTRUMENT WAS NOT RECOGNIZED ON ARM1. THE MONOPOLAR CURVED SCISSOR WAS REPLACED BY ANOTHER DURING SURGERY. POST-OPERATIVELY, INSTRUMENTS CHECKED ON THE PELVIS TRAINER AND THE MCS INSTRUMENT WAS WORKING. THE CUSTOMER REQUESTED FOR A COMPLETE CHECK OF THE SYSTEM BEFORE FURTHER SURGERY AND POSSIBLE REPLACEMENT OF ARM1. THE SURGEON CONTINUED TO USE ARM1 AS THE BIPOLAR WAS WORKING VERY WELL ON IT. THE SURGERY WAS PERFORMED WITH ALL 4 ARMS AND THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2334284 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-19 K11220905 0205 00886874112298

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES