BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 23698875 · Received December 2, 2025

    Report

    Report Number
    2955842-2025-47161
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    November 3, 2025
    Report Date
    January 14, 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
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE 8MM MEDIUM-LARGE CLIP APPLIER INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT WAS ANALYZED AND FOUND DURING ROBOT-ASSISTED LOW ANTERIOR RESECTION (LAR) SURGERY, THE SINGLE PORT MEDIUM-LARGE CLIP APPLIER SHOWED AWKWARD MOVEMENT AND CLIPS FAILED TO ATTACH PROPERLY; INSPECTION REVEALED A BROKEN WIRE, AND THE PROCEDURE WAS COMPLETED USING A BACKUP INSTRUMENT. FAILURE ANALYSIS IDENTIFIED A DISLODGED INSTRUMENT CABLE CRIMP AT THE DISTAL JOGGLE JOINT AS THE PRIMARY CAUSE OF THE COMPLAINT, LEADING TO A BROKEN JOGGLE CONSTRAINT CABLE AND IMPRECISE MOTION WITH YAW FRICTION. NO HOUSING DAMAGE OR MISSING MATERIAL WAS OBSERVED. IN-HOUSE TESTING CONFIRMED IMPRECISE INSTRUMENT MOTION, SPECIFICALLY YAW FAILURE, DESPITE PASSING RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT STRUGGLED TO STRAIGHTEN DURING YAW MANIPULATION, LIKELY DUE TO THE MISSING/DISLODGED CRIMP. THE PROBABLE ROOT CAUSE OF THE CUSTOMER REPORTED ISSUE OF DISLODGED INSTRUMENT CABLE CRIMP AND FUNCTIONAL TEST FAILURE IS ATTRIBUTED TO THE INSTRUMENT EXPERIENCING MORE LOAD THAN ANTICIPATED. THE CABLE CRIMP CAN BECOME DISLODGED DUE TO BACK-DRIVING OF WRIST AND JOGGLE JOINTS WITH THE INSERTION AXIS. APPLYING EXCESSIVE FORCE ON THE INSTRUMENT SHAFT AND/OR TIP DURING HANDLING, INSERTION, USAGE (OVERLOADING), OR REMOVAL CAN ALSO CAUSE THE CRIMP TO DISLODGE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS ISSUED A RETURN MATERIAL AUTHORIZATION (RMA) TO HAVE THE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE INSTRUMENT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE SURGEON USED A ROBOT SP MEDIUM-LARGE CLIP APPLIER FOR VESSEL LIGATION. THE SURGEON MENTIONED THAT THE MOVEMENT OF THE INSTRUMENT SEEMED A BIT AWKWARD. WHEN ATTEMPTING VESSEL LIGATION, THE CLIP DID NOT ATTACH PROPERLY AND FELL OFF. ANOTHER ATTEMPT WAS MADE TO ATTACH THE CLIP FOR LIGATION, BUT IT FAILED AGAIN. THE SURGEON REQUESTED TO CHECK IF THE INSTRUMENT WAS FAULTY. UPON DETACHING THE INSTRUMENT FROM THE ROBOT AND REMOVING THE INSTRUMENT SHEATH, IT WAS DISCOVERED THAT ONE WIRE WAS BROKEN. THE SURGERY WAS COMPLETED USING A BACKUP ROBOT INSTRUMENT OF THE SAME TYPE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION: ISSUE OCCURRED WHILE THE SURGEON ATTEMPTED TO CLAMP ON A VESSEL OR TISSUE BUNDLE. THE MOVEMENT OF THE INSTRUMENT SEEMED A BIT AWKWARD. CUSTOMER USED BACK-UP INSTRUMENT TO RESOLVE THE ISSUE. INSTRUMENT IS AVAILABLE FOR RETURN. NO PHOTOS OR VIDEOS ARE AVAILABLE FOR REVIEW. NO INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2809913 ENDOWRIST SP MEDIUM-LARGE CLIP APPLIER NAY INTUITIVE SURGICAL, INC 430005-57 U10221229 0014 00886874114292

    Patients

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