BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 23969027 · Received January 5, 2026

    Report

    Report Number
    2955842-2026-00055
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Date of Event
    December 17, 2025
    Report Date
    February 19, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114292
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE SINGLE PORT (SP) MEDIUM-LARGE CLIP APPLIER INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT WAS ANALYZED AND THE FINDINGS DID NOT REPLICATE OR CONFIRM THE CUSTOMER REPORTED EVENT. THE REPORTED ISSUE WITH THE INSTRUMENT WAS NOT REPLICATED NOR CONFIRMED. THE INSTRUMENT WAS EVALUATED AND PLACED ON AN IN-HOUSE TESTER. THE QAP (QUALITY ASSURANCE PROCEDURE) WAS PERFORMED AND PASSED. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. CLIP TEST, GRIPPING MISALIGNMENT, BUMPER TEST, AND INTUITIVE MOTION TESTING WAS PERFORMED AND PASSED. THE INSTRUMENT MOVED INTUITIVELY WIT FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIP TIPS OPENED AND CLOSE PROPERLY. THE INSTRUMENT WAS RETESTED AND PASSED ALL IN-HOUSE TESTING ALL THREE ATTEMPTS. A VISUAL INSPECTION OF GRIP TIPS, CABLES, AND ALL INTERNAL AND EXTERNAL COMPONENTS WAS PERFORMED AND PASSED DUE TO NO VISUAL DAMAGE OBSERVED. THERE WAS NO PROBLEM DETECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SINGLE PORT (SP) MEDIUM-LARGE CLIP APPLIER INSTRUMENT WOULD NOT FIRE THE CLIP. THE INSTRUMENT WORKED MULTIPLE TIMES PRIOR TO THE INCIDENT. THE INSTRUMENT WAS REMOVED AS IT WAS NOT NEEDED FOLLOWING THE NON-FIRE. NO FRAGMENT FELL INTO THE PATIENT. THE USER COMPLETED THE PROCEDURE AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201767 ENDOWRIST SP MEDIUM-LARGE CLIP APPLIER NAY INTUITIVE SURGICAL, INC 430005-62 K10240711 0002 00886874114292

    Patients

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