BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22014584 · Received May 13, 2025

    Report

    Report Number
    2955842-2025-20267
    Event Type
    Malfunction
    Date Received
    May 13, 2025
    Date of Event
    April 9, 2025
    Report Date
    April 22, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119785
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 PROGRASP FORCEPS 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.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PROGRASP FORCEPS WAS ANALYZED, AND THE FINDINGS DID NOT REPLICATE OR CONFIRM THE CUSTOMER REPORTED EVENT. THE INSTRUMENT WAS RETURNED WITH A REPORTED COMPLAINT THAT DOES NOT AFFECT FUNCTIONALITY. THE INSTRUMENT UNDERWENT INTERNAL AND EXTERNAL INSPECTION, AND NO ISSUES WERE DETECTED. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM AND PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS/TIPS OPENED, CLOSED, AND GRASPED PROPERLY AND ADEQUATELY. THE DETECTED BACKLASH OF THE GRIPS IS DUE TO THE DESIGN AND WITHIN THE SPECIFIED LIMITS. NO PRODUCT ISSUE WAS IDENTIFIED, AND THE PRODUCT IS CONSIDERED CONFORMING IN ITS CURRENT STATE. 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 AND RECOGNITION ISSUES. THE INSTRUMENT WAS VISUALLY INSPECTED AND EVALUATED FOR ITS MECHANICAL AND/OR ELECTRICAL CHARACTERISTICS. THE FAILURE ANALYSIS INVESTIGATIONS AND IN-HOUSE TESTING OF THE RETURNED INSTRUMENT REVEALED NO ISSUES RELATED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE PROGRASP FORCEPS INSTRUMENT'S HEAD WAS VERY LOOSE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTED INSTRUMENT DAMAGE WAS LOCATED AT THE DISTAL END, WHICH IS THE PORTION THAT ENTERS THE PATIENT¿S BODY. NO ADDITIONAL PHYSICAL DAMAGE WAS OBSERVED, INCLUDING NO VISIBLE BROKEN OR DAMAGED CABLES AT THE INSTRUMENT WRIST, NO DAMAGE TO THE INSTRUMENT TIPS, NO BENT OR MISALIGNED JAWS, AND NO PINS STICKING OUT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241969 ENDOWRIST PROGRASP FORCEPS NAY INTUITIVE SURGICAL, INC 471093-11 K10230810 0195 00886874119785

    Patients

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