BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 16926681 · Received May 13, 2023

    Report

    Report Number
    2955842-2023-13244
    Event Type
    Malfunction
    Date Received
    May 13, 2023
    Date of Event
    April 12, 2021
    Report Date
    July 8, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112380
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION FOUND THE PRIMARY FAILURE OF FAILED GRIP-CLIP TEST TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. HOWEVER, THE GRIP-CLIP TEST WAS PERFORMED AND FAILED ON ALL 5 ATTEMPTS. IN ADDITION, FAILURE ANALYSIS FOUND THE SECONDARY FAILURE OF BROKEN INPUT DISK TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE AN INPUT DISK BROKEN, LIKELY CAUSING THE CLIP TEST FAILURES. INPUT DISK #7 WAS FOUND BROKEN INTO PIECES INSIDE OF THE HOUSING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE SURGEON OBSERVED THAT THE 8MM LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WOULD NOT ALLOW THE CLIP TO CLOSE. AFTER SEVERAL ATTEMPTS WITH DIFFERENT CLIPS, THE ISSUE WAS UNRESOLVED. PER SERVICE REQUEST (SR) NOTES, A NEW CLIP APPLIER INSTRUMENT WAS OPENED AND USED TO COMPLETE THE PROCEDURE WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED-UP WITH THE REPORTER AND OBTAINED THE FOLLOWING INFORMATION FROM THE CUSTOMER ABOUT THE COMPLAINT: THE ROBOTICS COORDINATOR (ROCO) STATED THAT THERE WAS NO DAMAGE TO THE LARGE HEM-O-LOC CLIP APPLIER INSTRUMENT. NO CABLES WERE LOOSE OR BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357716 ENDOWRIST LARGE HEM-O-LOK CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470230-12 N10200113 0089 00886874112380

    Patients

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