BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 14861176 · Received June 29, 2022

    Report

    Report Number
    2955842-2022-12554
    Event Type
    Malfunction
    Date Received
    June 29, 2022
    Date of Event
    August 5, 2020
    Report Date
    August 19, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112670
    PMA / PMN Number
    K150837
    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 HORIZON SMALL CLIP APPLIER INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS COULD NOT REPLICATE NOR CONFIRM THE REPORTED EVENT. INCOMPLETE FAILURE ANALYSIS OCCURRED BECAUSE THE INSTRUMENT COULD NOT BE RECOGNIZED. FUNCTIONAL TEST COULD NOT BE PERFORMED. YELLOW LIGHT ON SYSTEM ARM INDICATED THE INSTRUMENT COULD NOT BE USED. ERROR CODE 282, INDICATING ONE OR MORE SENSORS WERE DETECTED BUT NOT ALL SENSORS WERE PRESENT. INSPECTION UPON REMOVAL OF THE INSTRUMENT HOUSING FOUND A CORRODED AND CONTAMINATED IDENTIFICATION BOARD. THE ISSUE IS ATTRIBUTED TO IMPROPER CLEANING DURING REPROCESSING. NO CABLE DAMAGE WAS OBSERVED AT THE WRIST ASSEMBLY. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO PROCEDURE VIDEO OR IMAGE WAS SUBMITTED FOR REVIEW. A REVIEW OF THE SYSTEM LOGS FOR THE EVENT DATE OF (B)(6) 2021 HAS BEEN PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER AND THE FOLLOWING WAS OBSERVED: THERE WERE NO OBSERVED EVENTS IN THE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE AND THE LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. A REVIEW OF THE INSTRUMENT LOG FOR THE SMALL CLIP APPLIER INSTRUMENT LOT # T10180515-0097 ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON THE REPORTED EVENT DATE ON SYSTEM SK1878. THE INSTRUMENT WAS USED TO CLIP 5 TIMES DURING THE PROCEDURE. THE ALLEGED EVENT OCCURRED ON THE 68TH USE OF THE INSTRUMENT. INSTRUMENT HAS 32 REMAINING USES REMAINING. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE CLIP APPLIER INSTRUMENT MOVED WITH UNINTUITIVE MOTION. UNINTUITIVE MOTION COULD LEAD TO SUBSEQUENT TISSUE DAMAGE. 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 DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PHYSICIAN OBSERVED NON-INTUITIVE MOVEMENT ON THE HORIZON SMALL CLIP APPLIER INSTRUMENT. NO ISSUE WITH THE INSTRUMENT'S PRIMARY FUNCTIONALITY (CLIP APPLICATION) WAS REPORTED. THE PROCEDURE WAS PERFORMED WITH A BACK-UP INSTRUMENT. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INTO THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. ON 26-AUG-2020 INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM AN ISI FIELD SERVICE ENGINEER (FSE), WHO SPOKE WITH THE PHYSICIAN REGARDING THE REPORTED EVENT: THE SMALL CLIP APPLIER INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO ABNORMALITIES WERE OBSERVED. THE SURGEON CONFIRMED THE ISSUE WAS NOT RELATED TO INSTRUMENT RECOGNITION. SOMETIMES THE INSTRUMENT DID NOT MOVE AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090043 ENDOWRIST CLIP APPLIER, SMALL, HORIZON NAY INTUITIVE SURGICAL, INC 470401-05 T10180515 0097 00886874112670

    Patients

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