BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 15842908 · Received November 22, 2022

    Report

    Report Number
    2955842-2022-15438
    Event Type
    Malfunction
    Date Received
    November 22, 2022
    Date of Event
    October 24, 2022
    Report Date
    October 24, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112465
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MEDIUM-LARGE CLIP APPLIER INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS DID NOT REPLICATE NOR CONFIRM THE 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 A FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT PASSED THE CLIP TEST ON MULTIPLE TRIES. UPON VISUAL INSPECTION, THE GRIP TIPS WERE NOT OBSERVED TO BE MISALIGNED. THE INSTRUMENT WAS FULLY FUNCTIONAL. NO PRODUCT ISSUE WAS IDENTIFIED. ISSUES RELATED TO INSTRUMENT ERRORS OR COMPLICATIONS USING THE INSTRUMENT REPORTED BY THE USER WITH NO UNDERLYING PRODUCT ISSUE MAY BE RELATED TO CUSTOMER-INDUCED PROBLEMS, INCLUDING MISUSE OF THE PRODUCT AND RECOGNITION ISSUES. A REVIEW OF THE DEVICE LOGS FOR THE MLCA (PART#: 470327-12/ LOT#: N12210614 - 0038) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THIS REVIEW OF THE LOGS, THE MLCA WAS LAST USED ON (B)(6) 2022 VIA SYSTEM SERIAL#: (B)(4). THERE WERE 84 USES REMAINING AFTER THIS LAST USAGE. THIS LAST USAGE OF THE DEVICE PER THE LOG REVIEW MATCHES THE REPORTED EVENT DATE, INDICATING THAT THE INSTRUMENT WAS NOT USED AFTER THE DATE OF THE REPORTED EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: PER THE DESCRIPTION OF THE COMPLAINT, THE CLIP APPLIER MAY HAVE INCURRED A FAILURE MODE THAT IS KNOWN TO IMPACT CLIP APPLICATION EFFECTIVENESS. DEFICIENCIES IN CLIP APPLICATION MAY LEAD TO INADEQUATE HEMOSTASIS. 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 A DA VINCI-ASSISTED ABDOMINOPERINEAL RESECTION SURGICAL PROCEDURE, THE CLIP DID NOT COME OFF FROM THE MEDIUM-LARGE CLIP APPLIER (MLCA). THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY WITH A BACKUP MLCA. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT AND ACCESSORY WERE NOT INSPECTED PRIOR TO USE. THE WAS NO PATIENT IMPACT DUE TO THE MLCA ISSUE. THE ISSUE OCCURRED AFTER CLIPPING INSIDE THE PATIENT. THE CLIP WAS STIFF WHEN IT WAS ATTACHED TO THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2688262 ENDOWRIST MEDIUM-LARGE CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470327-12 N12210614 0038 00886874112465

    Patients

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