BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST;DAVINCI SI

    MDR report key: 13706756 · Received March 9, 2022

    Report

    Report Number
    2955842-2022-10547
    Event Type
    Malfunction
    Date Received
    March 9, 2022
    Date of Event
    October 31, 2021
    Report Date
    February 9, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874111352
    PMA / PMN Number
    K050369
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PRECISE BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN GRIP CABLE AT THE DISTAL IDLER PULLEY. THE DISTAL IDLER PULLEY SPUN FREELY AND DID NOT EXHIBIT ANY DAMAGE. THE ROOT CAUSE IS ATTRIBUTED TO A COMPONENT FAILURE. ADDITIONAL OBSERVATION NOT REPORTED WAS THE INSTRUMENT WAS FOUND TO HAVE VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVED ON THE MAIN TUBE. THE SCRATCH MARKS WERE 0.087¿ - 0.157 IN LENGTH AND WERE NOT ALIGNED WITH THE TUBE AXIS. THE ROOT CAUSE IS TYPICALLY ATTRIBUTED TO MISHANDLING / MISUSE. A REVIEW OF THE INSTRUMENT LOG FOR THE PRECISE BIPOLAR FORCEPS INSTRUMENT (PN# 420110-12 / LOT# N10201207-451) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2021 ON SYSTEM (B)(4) FOR APPROXIMATELY 1 MINUTE 39 SECONDS. THE ALLEGED EVENT OCCURRED ON THE 10TH USE OF THE INSTRUMENT WITH NO LIVES REMAINING. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY RELATED OR DUPLICATE COMPLAINTS INVOLVING THIS PRODUCT AND/OR THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: FAILURE ANALYSIS ACKNOWLEDGES MATERIAL WAS MISSING FROM A PORTION OF THE DEVICE THAT ENTERS THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE WAS NO REPORT FROM THE CUSTOMER THAT A FRAGMENT FROM THE INSTRUMENT FELL INTO THE PATIENT DURING THE PROCEDURE. WHILE THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT AND NO REPORT OF FRAGMENTS FALLING INTO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FRAGMENT(S) DID FALL INTO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE PRECISE BIPOLAR FORCEPS WAS FOUND TO HAVE A TORN CABLE. A BACKUP INSTRUMENT OF THE SAME KIND WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) HAS PERFORMED FOLLOW-UP TO REQUEST ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1854654 ENDOWRIST;DAVINCI SI PRECISE BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 420110-12 N10201207 451 00886874111352

    Patients

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