BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 16321546 · Received February 8, 2023

    Report

    Report Number
    2955842-2023-10561
    Event Type
    Malfunction
    Date Received
    February 8, 2023
    Date of Event
    January 13, 2023
    Report Date
    January 13, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119778
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CADIERE FORCEPS (CF) INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUE. THERE WAS NO EXTERNAL COLLISION. THERE WAS NO SHAKINESS OR FRICTION. THE CF INSTRUMENT DID NOT MOVE AS THE SURGEON INTENDED. THE CUSTOMER RESEATED THE STERILE ADAPTER (SA) TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY. THE DRAPE AND THE CF INSTRUMENT WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ABDOMINOPERINEAL RESECTION PROCEDURE, CADIERE FORCEPS (CF) INSTRUMENT MOVED NON-INTUITIVELY. BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING NON-INTUITIVE MOTION OF THE CF INSTRUMENT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED FOR TROUBLESHOOTING ASSISTANCE. THE TSE CONFIRMED NO RELATED ERROR IN THE LOGS. THE TSE ADVISED THE CUSTOMER TO RESEAT THE STERILE ADAPTER (SA) TO RESOLVE THE ISSUE. PROCEDURE LOG REVIEW CONFIRMS THE OCCURRENCE OF A PROCEDURE USING A CF INSTRUMENT WITH LOT# K12210927 / SEQUENCE 0185 ON (B)(6)2023 USING SYSTEM SK3171. A REVIEW OF THE INSTRUMENT LOG FOR THE CF INSTRUMENT LOT# K12210927 / SEQUENCE 0185 ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON THE REPORTED EVENT DATE OF (B)(6)2023 ON SYSTEM SK3171. THE INSTRUMENT MET ITS END OF LIFE, IT HAS 0 REMAINING USABLE LIFE. THE PROBABLE ROOT CAUSE OF NON-INTUITIVE MOTION OF THE CF INSTRUMENT IS ATTRIBUTED TO IMPROPER CUSTOMER SETUP. BASED ON TSE NOTES, THE SYSTEM ISSUE WAS DUE TO A LOOSELY CONNECTED, IMPROPERLY SEATED SA. THIS COMPLAINT IS CONSIDERED AS A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE CADIERE FORCEPS INSTRUMENT MOVED WITH UNINTUITIVE MOTION. INFORMATION IS AMBIGUOUS AND IT IS UNKNOWN IF INSTRUMENT MOVED UNEXPECTEDLY JERKED/JUMPED/SWUNG/BOWED, MOVED IN AN UNEXPECTED/UNINTENDED/UNKNOWN WAY. UNINTUITIVE MOTION COULD LEAD TO SUBSEQUENT TISSUE DAMAGE. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ABDOMINOPERINEAL RESECTION SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THE CADIERE FORCEPS (CF) INSTRUMENT MOVED NON-INTUITIVELY. THE TSE CONFIRMED NO RELATED ERROR IN THE LOGS. THE TSE ADVISED THE CUSTOMER TO RESEAT THE STERILE ADAPTER (SA) TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2230612 ENDOWRIST CADIERE FORCEPS NAY INTUITIVE SURGICAL, INC 471049-08 K12210927 0185 00886874119778

    Patients

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