BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21089431 · Received January 7, 2025

    Report

    Report Number
    2955842-2025-00164
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    December 13, 2024
    Report Date
    December 13, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874120767
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FORCE BIPOLAR INSTRUMENT WAS RETURNED FOR FAILURE ANALYSIS (FA) AND FA WAS ABLE TO CONFIRM THE REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A SEGMENT OF THE CONDUCTOR WIRE DISLODGED AT THE DISTAL CLEVIS APPEARING LOOSE CAUSING THE GRIP TIPS NOT TO OPEN AND CLOSE CORRECTLY AND NOT RELEASE THE TISSUE CORRECTLY. A LOOP OF THE WIRE PROTRUDES ABOVE THE OUTER SURFACE OF THE DISTAL CLEVIS. THE WIRE INSULATION WAS DAMAGED, AND THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. THE CONDUCTOR WIRE WAS NOT EXPOSED. COMPONENTS ADJACENT TO THE DISLODGED WIRE DO NOT SHOW DAMAGE. ADDITIONAL OBSERVATION RELATED TO CUSTOMER COMPLAINT: THE INSTRUMENT WAS FOUND TO HAVE DAMAGED CONDUCTOR WIRE INSULATION AT THE DISTAL CLEVIS. THERE WAS NO FRAGMENTATION OF THE INSULATION, AND THE INTERNAL CONDUCTOR WIRES WERE NOT EXPOSED. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE FORCE BIPOLAR INSTRUMENT INVOLVED WITH THIS COMPLAINT; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. AS OF 12/17/2024, A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY RELATED OR DUPLICATE COMPLAINTS INVOLVING THIS PRODUCT AND/OR THIS EVENT. A REVIEW OF THE INSTRUMENT LOG FOR THE INSTRUMENT (471405-06 / K10231109 0286) ASSOCIATED WITH THIS EVENT WAS PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2024 ON SYSTEM (B)(6) DURING A BENIGN HYSTERECTOMY SURGICAL PROCEDURE. THE INSTRUMENT HAD 2 USES REMAINING AFTER LAST USE.

    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 SURGICAL PROCEDURE, THE TIP OF FORCE BIPOLAR INSTRUMENT DID NOT COME OUT OF THE PORT. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CLINICAL ENGINEER AND OBTAINED THE FOLLOWING INFORMATION: THE FORCE BIPOLAR INSTRUMENT WAS INSPECTED PRIOR TO USE. THERE WAS NOTHING OUT OF ORDINARY ON IT. THE WRIST PART WAS DISLODGED WHILE THE UTERUS WAS PLACED IN THE COLLECTION BAG. THE INSTRUMENT GOT CAUGHT WITH PORT AND COULD NOT REMOVE OUTSIDE. THE INSTRUMENT WAS REMOVED TOGETHER WITH CANNULA, AND PORT INCISION WAS NOT INCREASED. THE INSTRUMENT JAWS WERE NOT STUCK ON TISSUE WHEN ISSUE OCCURRED. THERE WAS NO UNEXPECTED TISSUE REMOVAL. THERE WAS NO BLEEDING. THE PROCEDURE WAS COMPLETED ROBOTICALLY AS PLANNED. THE INSTRUMENT WAS AVAILABLE FOR RETURN TO ISI FOR EVALUATION. THERE WERE NO PHOTOGRAPHIC IMAGES OR VIDEO RECORDINGS OF PROCEDURE FOR ISI REVIEW. THE INSTRUMENT WAS NOT IN STRONG GRIP MODE AT THE TIME OF EVENT. THERE WERE NO COLLISIONS WITH OTHER INSTRUMENT OR TOOLS. PATIENT DEMOGRAPHICS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1235197 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K10231109 0286 00886874120767

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES.