BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23641462 · Received November 25, 2025

    Report

    Report Number
    2955842-2025-46263
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Date of Event
    November 8, 2025
    Report Date
    January 16, 2026
    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
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 26-NOV-2025: THERE WAS NO PATIENT HARM OR POST-SURGICAL COMPLICATIONS THAT TOOK PLACE DUE TO THE REPORTED EVENT. THE CLIP APPLIER WAS UNFORTUNATELY NOT SAVED AND THEREFORE NOT RETURNING TO ISI FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. DURING A PROCEDURE, THE CUSTOMER CONTACTED TECH SUPPORT REPORTING THAT THE LARGE CLIP APPLIER WAS DROPPING CLIPS. TECHNICAL SUPPORT ENGINEER (TSE) ADVISED ENSURING FULL OPENING AND MECHANICAL GEOMETRY (FOMG) BY ROLLING THE WRIST AND RESEATING THE CLIPS. THE CLIPS THEN FIRED AS EXPECTED, WITH NO FURTHER ISSUES OR ACTION REQUIRED. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THAT THE INSTRUMENT BE RETURNED FOR FAILURE ANALYSIS TESTING. AS OF THE DATE OF THIS REPORT, THE PRODUCT HAS NOT YET BEEN RECEIVED. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE ISI DEVICE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    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 CHOLECYSTECTOMY SURGICAL PROCEDURE, SURGEON, CONTACTED TECHNICAL SUPPORT AND REPORTED THAT THE LARGE CLIP APPLIER INSTRUMENT WAS DROPPING CLIPS. TSE HAD SURGEON ENSURE THE FULL OPENING MAXIMUM GRIP (FOMG) WAS ACHIEVED WITH ROLLING THE WRIST. THERE WERE NO FURTHER ISSUES AFTER RESEATING THE CLIPS AND ENSURED THE CLIPS FIRED AS EXPECTED. NO FURTHER ACTION REQUIRED. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 19-NOV-2025: THE SR. CLINICAL PARTNER, STATED THE CLIPS WOULD FALL INSIDE THE PATIENT BUT COULD NOT BE SURE UNTIL HE SPOKE WITH THE DOCTOR LATER IN THE AFTERNOON. HE MENTIONED THE SURGEON CALLED IN THE ISSUE TO TECHNICAL SUPPORT AND WAS ABLE TO RESOLVE THE ISSUE. THE CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2602864 ENDOWRIST LARGE HEM-O-LOK CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470230-12 K10220523 0063 00886874112380

    Patients

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