BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST;DAVINCI SI

    MDR report key: 14247393 · Received April 29, 2022

    Report

    Report Number
    2955842-2022-11308
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    November 1, 2021
    Report Date
    March 29, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874111505
    PMA / PMN Number
    K180033
    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 THE MONOPOLAR CURVED SCISSORS ASSOCIATED WITH THE COMPLAINT AND COMPLETED THE INVESTIGATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT OF DAMAGED CABLE AT TIP. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF BROKEN GRIP CABLE. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN GRIP CABLE AT THE DISTAL END. THE ROOT CAUSE OF BROKEN - DISTAL INSTRUMENT GRIP CABLES WAS ATTRIBUTED TO A COMPONENT FAILURE. AN ADDITIONAL OBSERVATION NOT REPORTED BY THE SITE WAS ALSO IDENTIFIED. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE ORANGE TUBE EXTENSION AT THE DISTAL END. THE ROOT CAUSE WAS ATTRIBUTED TO MISHANDLING/MISUSE. A REVIEW OF THE SITE'S COMPLAINTS DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. A REVIEW OF THE INSTRUMENT LOG FOR PART# 420179-23/LOT# N10210524 0546 ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE MONOPOLAR CURVED SCISSORS WAS LAST USED ON (B)(6) 2021 ON SYSTEM SH2301 WITH 1 LIVES REMAINING. A REVIEW OF AN IMAGE PROVIDED BY THE CUSTOMER CONFIRMED A BROKEN GRIP CABLE. BASED ON THE ADDITIONAL INFORMATION OBTAINED FROM FAILURE ANALYSIS INVESTIGATION, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE INSTRUMENT EXHIBITED SIGNS INDICATIVE OF THERMAL DAMAGE. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE THERMAL DAMAGE TO OCCUR. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS WAS FOUND TO HAVE A DAMAGED CABLE AT THE TIP. A BACKUP INSTRUMENT OF THE SAME KIND WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN THE INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY; HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION. PER CUSTOMER, THE MONOPOLAR CURVED SCISSORS WAS INSPECTED PRIOR TO USE AND NO ANOMALY WAS NOTED. THE CABLE BROKE DURING PROCEDURE. THERE WAS NO REPORT OF ANY COLLISION OR ARCING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58273 ENDOWRIST;DAVINCI SI MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 420179-23 N10210524 0546 00886874111505

    Patients

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