BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE-SITE

    MDR report key: 16840586 · Received April 28, 2023

    Report

    Report Number
    2955842-2023-12284
    Event Type
    Malfunction
    Date Received
    April 28, 2023
    Date of Event
    March 28, 2023
    Report Date
    April 4, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874113721
    PMA / PMN Number
    K152448
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING PHYSICAL DAMAGE, AN INVESTIGATION IS IN PROGRESS. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY HOOK INSTRUMENT RELATED TO THIS COMPLAINT FOR EVALUATION, BUT FAILURE ANALYSIS INVESTIGATION HAS NOT BEEN COMPLETED. THEREFORE, THE ROOT CAUSE OF THE REPORTED FAILURE MODE HAS NOT YET BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED FOLLOWING THE COMPLETION OF PRODUCT EVALUATION AND IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE PERMANENT CAUTERY HOOK INSTRUMENT HAD THE TIP AND THE BODY PARTS SEPARATED. 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 AS UNINTENDED FRAGMENT(S) FALLING INTO THE PATIENT MAY REQUIRE SURGICAL INTERVENTION.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING PHYSICAL DAMAGE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT WAS ANALYZED AND FOUND TO HAVE THE MAIN TUBE BROKEN. NO MATERIAL WAS FOUND MISSING. COMMON CAUSES OF THE FAILURE MODE ARE TYPICALLY ATTRIBUTED TO MISHANDLING/MISUSE. THE COMPLAINT REGARDING PHYSICAL DAMAGE WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT HAD THE TIP AND THE BODY PARTS SEPARATED. A BACKUP INSTRUMENT OF SAME KIND WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITY. THE CUSTOMER CONFIRMED THAT ARCING WAS NOT OBSERVED, AND NO FRAGMENT FELL INSIDE OF THE PATIENT. THE INSTRUMENT BROKE WHEN THE CUSTOMER ATTEMPTED TO REMOVE THE INSTRUMENT. IT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THERE WAS NO INJURY TO THE PATIENT AS RESULT OF THE EVENT. IT WAS UNKNOWN WHAT CAUSED THE INSTRUMENT TO BREAK AND HOW LONG IT WAS IN USE.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566878 SINGLE-SITE PERMANENT CAUTERY HOOK NAY INTUITIVE SURGICAL, INC 478090-03 K10230126 0025 00886874113721

    Patients

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