BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 14251485 · Received April 29, 2022

    Report

    Report Number
    2955842-2022-11328
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    February 28, 2022
    Report Date
    March 30, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112465
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED ITS INVESTIGATION. THE FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT OF "TIP BROKEN." FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF BROKEN GRIP TIPS TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN GRIP AT THE CLIP GROOVES. A PIECE APPROXIMATELY 0.068" X 0.086" WAS FOUND TO BE BROKEN OFF THE GRIPS. THE BROKEN PIECE WAS NOT RETURNED. THE ROOT CAUSE OF THE FAILURE IS TYPICALLY ATTRIBUTED MISHANDLING/MISUSE SUCH AS EXCESS FORCE APPLIED TO THE INSTRUMENT JAWS. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY RPMS ANALYST. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. HOWEVER, THE SYSTEM LOG INDICATES THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT ASSOCIATED WITH THIS EVENT WAS LAST USED ON (B)(6) 2021 ON SYSTEM (B)(4). THE INSTRUMENT HAD 39 LIVES REMAINING. THIS COMPLAINT IS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: FAILURE ANALYSIS CONFIRMED THE INSTRUMENT'S GRIP WAS AT THE GRIP BASE. THIS INSTRUMENT IS DESIGNED WITH A GRIP PIN ON THE DISTAL END ALLOWING ARTICULATION OF THE INSTRUMENT ASSEMBLIES THEY ARE HOLDING TOGETHER AND IS SECURED TO THE DEVICE BY SWAGING. IF THE PIN IS NOT PROPERLY FUSED TOGETHER, THE PIN COULD BECOME DISLODGED AND FALL INTO THE PATIENT. 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

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL CHOLECYSTECTOMY PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER TIP WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. FOLLOW-UP WAS PERFORMED AND ADDITIONAL INFORMATION WAS OBTAINED. IT WAS CONFIRMED THAT NO PIECES WERE BROKEN OFF INSIDE THE PATIENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETENTION OF A FOREIGN MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97756 ENDOWRIST MEDIUM-LARGE CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470327-10 N10180423 0122 00886874112465

    Patients

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