BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 15397491 · Received September 10, 2022

    Report

    Report Number
    2955842-2022-13923
    Event Type
    Malfunction
    Date Received
    September 10, 2022
    Date of Event
    June 21, 2022
    Report Date
    August 10, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112267
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ISI HAS NOT RECEIVED THE PROGRASP FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT. THEREFORE, THE ROOT CAUSE OF THE ALLEGED CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT ARE RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS HAS BEEN PERFORMED. THERE WERE NO OBSERVED EVENTS IN THE AVAILABLE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE, AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. THE PROGRASP FORCEPS INVOLVED IN THIS CASE WITH PART# 470093-11, LOT# N11191007- 0082 HAD 4 USES REMAINING. THE IMAGE SENT BY THE CUSTOMER WAS REVIEWED BY A CLINICAL DEVELOPMENT ENGINEERING (CDE) AND THE FOLLOWING INFORMATION WAS RECEIVED: THE "BURR" COULD NOT BE SEEN ON THE CABLES. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE PROGRASP FORCEPS HAD A PIECE OF WIRE STICKING OUT AT THE WRIST WHICH CAUSED THE INTESTINE TO CATCH ON. THERE WAS NO INJURY TO THE INTESTINE AS WELL AS NO MEDICAL INTERVENTION REQUIRED FOR THE AFFECTED TISSUE. ALTHOUGH THERE WAS NO INJURY REPORTED, IF THE ISSUE WERE TO RECUR, IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Additional Manufacturer Narrative · 0

    ON 10/24/2022, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM FAILURE ANALYSIS OF THE PROGRASP FORCEPS: INTUITIVE HAS RECEIVED THE PART ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A FRAYED GRIP CABLE AT THE DISTAL END. THE FRAYED CABLE STRANDS DID NOT STICK OUT AT THE WRIST. THE ROOT CAUSE IS ATTRIBUTED TO A COMPONENT FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE PROGRASP FORCEPS HAD A MICROSCOPIC BURR ON THE WIRE WITH WHICH THE INSTRUMENT MOVED. THIS CAUSED THE INTESTINE TO CATCH ON IT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION: THE ¿BURR¿ WAS A PIECE OF WIRE STICKING OUT AT THE WRIST. THERE WAS NO DAMAGE TO THE INSTRUMENT PRIOR TO USAGE AND NO COLLISION OF THE INSTRUMENT WITH OTHER INSTRUMENTS BEFORE THE ONSET OF THE BURR. THE INSTRUMENT WORKED AS EXPECTED AND THERE WAS NO LOSS OF FUNCTION. THERE WAS NO INJURY TO THE INTESTINE DUE TO THE ¿BURR¿ CATCHING ON THE INTESTINE AND NO REPAIRS WERE REQUIRED. THE PROCEDURE WAS COMPLETED ROBOTICALLY AND THERE WAS A SHORT DELAY OF 5 MINUTES DUE TO INSTRUMENT REPLACEMENT. THERE WERE NO FRAGMENTS FROM THE INSTRUMENT WHICH FELL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140012 ENDOWRIST PROGRASP FORCEPS NAY INTUITIVE SURGICAL, INC 470093-11 N11191007 0082 00886874112267

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES