BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21569775 · Received March 11, 2025

    Report

    Report Number
    2955842-2025-06856
    Event Type
    Malfunction
    Date Received
    March 11, 2025
    Date of Event
    February 12, 2025
    Report Date
    February 12, 2025
    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
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS FOUND TO HAVE A BENT GRIP AT THE BASE OF THE GRIP. NO BROKEN COMPONENTS FOUND. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO DAMAGE DURING USE, AS MODERATE MISALIGNMENT OF GRIP TIPS CAN OCCUR DUE TO GRASPING HARD TISSUE OR OBJECTS, OR THROUGH COLLISIONS WITH OTHER INSTRUMENTS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING INFORMATION: ACCORDING TO CENTRAL STERILE (CS), THEY DID NOT NOTICE ANY BENT METAL STRUCTURE NEAR THE PULLEY WHEN YOU HAD THE LARGE CLIP APPLIER INSTRUMENT IN CENTRAL PROCESSING. ACCORDING TO CS, THEY DID NOT FIND ANY MATERIAL EVER ¿STUCK¿ TO THIS METAL COMPONENT THAT THEY ATTEMPTED TO REMOVE, AND THEY ARE NOT AWARE OF THE INSTRUMENT BEING DROPPED OR COLLIDED AGAINST ANOTHER OBJECT AT ANY TIME. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT TO PERFORM FAILURE ANALYSIS (FA). THE REPORTED EVENT WITH THE INSTRUMENT COULD NOT BE REPLICATED NOR CONFIRMED. FA COULD NOT VERIFY THE CUSTOMER REPORTED EVENT. NO BROKEN COMPONENTS FOUND. THE REPORTED COMPLAINT COULD NOT BE REPLICATED, NOR CONFIRMED, DURING THE FA INVESTIGATION. BASED ON THE INVESTIGATION RESULTS, CUSTOMER REPORTED ISSUES MAY BE DUE TO OTHER FACTORS UNRELATED TO THE PRODUCT. ADDITIONAL FINDING NOT REPORTED BY SITE: DURING VISUAL INSPECTION, INSTRUMENT WAS FOUND TO HAVE A GRIP TANG - BENT. COMPONENTS ADJACENT TO BENT GRIP TANG DO NOT SHOW DAMAGE. ROOT CAUSE FOR THIS FAILURE IS NOT DETERMINABLE/APPLICABLE. A DEVICE HISTORY RECORD (DHR) REVIEW FOR THE DEVICE(S) INVOLVED WITH THE REPORTED EVENT HAS BEEN COMPLETED. NO NON-CONFORMANCES WERE IDENTIFIED TO BE RELATED TO THIS COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WAS TRANSFERRED TO THE FAILURE ANALYSIS ENGINEERING (FAE) TEAM. FAE FOUND INITIAL FINDINGS WERE PARTIALLY CONFIRMED. THE INSTRUMENT WAS RETURNED WITH A COMPLAINT THAT THE 'TIP BROKE OFF', HOWEVER FOLLOW UP INFORMATION FROM THE REPORTED CONFIRMS THE ISSUE IS THE 'BENT METAL STRUCTURE', RATHER THAN A BROKEN TIP. INSPECTION OF THE INSTRUMENT CONFIRMS THAT THE GRIP TANG FOR ONE OF THE GRIPS IS BENT FROM ITS NORMAL POSITION. THE BEND IN THE TANG PREVENTS THE GRIPS FROM ALIGNING WITH THE MAIN TUBE. THE GRIPS ARE ANGLED TO ONE SIDE. INSTRUMENT WAS INSTALLED ON AN IN-HOUSE SYSTEM BUT COULD NOT BE INSERTED THROUGH THE CANNULA DUE TO THE BENT COMPONENT. THE MOST PROBABLE ROOT CAUSE FOR A BENT GRIP TANG IS ATTRIBUTED TO THE USER, AND MAY OCCUR DUE TO AN EXTERNAL COLLISION, DAMAGE THROUGH USE, OR REPROCESSING. WHILE A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED, THE INFORMATION FROM THE CUSTOMER REGARDING THE ISSUE EXPERIENCED IN ASSOCIATION WITH FAILURE ANALYSIS FINDINGS AND REPLICATION TESTING RESULTS ALONG WITH CROSS-FUNCTIONAL DISCUSSIONS REGARDING THE OBSERVED FAILURE MODE OF BENT GRIP TANG WERE USED TO ATTRIBUTE THE POTENTIAL ROOT CAUSE(S) OF THIS FAILURE MODE TO (1) DRIVING OF THE GRIP TIPS WITH FULL INSERTION AXIS FORCE AGAINST A RIGID OBJECT (MAY CAUSE THE ENTIRE GRIP SET TO TWIST AND THE TANG TO BE FORCED INTO THE FORCE AMP PULLEY BENDING IT) AND (2) FORCING THE INSTRUMENT REMOVAL THROUGH THE CANNULA (MAY CAUSE THE GRIP TANG TO GET CAUGHT BY THE CIRCUMFERENCE OF THE CANNULA, CAUSING THE GRIP TANG TO BECOME BENT).

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT INVOLVED WITH THIS COMPLAINT; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE TIP BROKE OFF A LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT TIP WAS NOT COMPLETELY DETACHED FROM THE INSTRUMENT. THE ISSUE WAS DISCOVERED DURING CENTRAL PROCESSING OUTSIDE OF A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338769 ENDOWRIST LARGE HEM-O-LOK CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470230-12 K10220614 0270 00886874112380

    Patients

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