BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 19726869 · Received July 11, 2024

    Report

    Report Number
    2955842-2024-16503
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    March 13, 2024
    Report Date
    June 18, 2024
    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
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS ISSUED A RETURN MATERIAL AUTHORIZATION (RMA) TO HAVE THE INTUITIVE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE PRODUCT 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. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS COULD NOT REPRODUCE THE EXTERNAL EVENT TO BE RELATED TO THE REPORTED COMPLAINT. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM, PASSED THE RECOGNITION AND ENGAGEMENT TEST. THE INSTRUMENT PASSED THE CLIP TEST. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE INSTRUMENT WAS FULLY FUNCTIONAL. 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, OR OTHER FACTORS NOT DIRECTLY RELATED TO THE DEVICE. ADDITIONAL OBSERVATION(S) NOT REPORTED BY SITE: THE INSTRUMENT WAS FOUND TO HAVE HAIRLINE CRACKS ON GRIP INPUT DISK #7 OTHER BACKEND COMPONENTS ADJACENT TO THE CRACKED INPUTS DO NOT SHOW DAMAGE. THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ESOPHAGECTOMY TRANSTHORACIC - CHEST ANASTOMOSIS SURGICAL PROCEDURE, THE LARGE CLIP APPLIER INSTRUMENT HAD MOVEMENT WITHOUT CONTROL. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE OCCURRED WHILE THE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS FROM THE SURGEON CONSOLE. THE INSTRUMENT DID NOT ACT PROPERLY WHEN SURGEON TOOK THE CONTROL (E.G. WHEN SURGEON ASKED RIGHT, INSTRUMENT DIDN¿T GO EXACTLY TO THE RIGHT). THE INSTRUMENT DID NOT MOVE EXACTLY TO THE MOVEMENT ASKED. IT WORKED WITHOUT PRECISION. THERE WERE NO EXTERNAL COLLISIONS. THE ISSUE WAS PERSISTENT OR INTERMITTENT. WHEN THE ISSUE OCCURRED, THE SURGEON TRIED TO ACCESS TO THE VESSEL. THE DEVICE WAS INSPECTED PRIOR TO USE, AND THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY. NO PHOTOGRAPHIC IMAGES OF THE DEVICE(S) OR A VIDEO RECORDING OF THE PROCEDURE AVAILABLE FOR IS REVIEW. IT WAS UNKNOWN AT APPROXIMATELY WHAT TIME THE ISSUE OCCURRED. THE UNEXPECTED MOTION DID NOT OCCUR WHEN ATTEMPTING TO PLACE A CLIP AROUND A VESSEL/TISSUE AND THE UNEXPECTED MOTION DID NOT OCCUR DURING CLIP CLOSURE. AT THE TIME OF EVENT, THE CLIP DID NOT BECOME DISLODGED FROM THE INSTRUMENT AND FALL INTO PATIENT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315938 ENDOWRIST LARGE HEM-O-LOK CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470230-12 K10220208 0040 00886874112380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES.