BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 15956193 · Received December 10, 2022

    Report

    Report Number
    2955842-2022-15841
    Event Type
    Malfunction
    Date Received
    December 10, 2022
    Date of Event
    September 29, 2022
    Report Date
    November 10, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    UDI-DI
    00886874116555
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    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 30-DEGREE ENDOSCOPE PLUS WAS ANALYZED AND FOUND TO HAVE A DAMAGED/ CRACKED SAPPHIRE DISTAL WINDOW. THERE WAS POOR FOCUS AT ALL DISTANCES IN THE LEFT EYE. THE ENDOSCOPE ADAPTER (AEA) WAS DAMAGED OR HAD A FRICTION ISSUE. THE DESICCANT CONTAINER WAS DAMAGED OR HAD LOOSE DESICCANT BALLS. THE CABLE WAS DEFORMED. THE HOUSING WAS ALSO DISCOLORED. THE COMPLAINT REGARDING THE PHYSICAL DAMAGE WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. NO IMAGE OR VIDEO WAS AVAILABLE FOR REVIEW. A REVIEW OF THE 30-DEGREE ENDOSCOPE (PART NUMBER 470057-08/ LOT NUMBER 901963) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE 30-DEGREE ENDOSCOPE WAS LAST USED IN A PROCEDURE ON (B)(6) 2022 ON SYSTEM SL0764. THE ALLEGED ENDOSCOPE HAD 1870 USES REMAINING AFTER LAST PROCEDURAL USAGE. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO DAMAGE FROM MISHANDLING/MISUSE, WHICH MAY INCLUDE AN ACCIDENTAL DROP OF THE ENDOSCOPE, INADVERTENT COLLISIONS WITH HARD SURFACES, OR IMPROPER CLEANING DURING REPROCESSING. THIS ISSUE CAN BE RESOLVED BY USING AN ALTERNATE INSTRUMENT TO COMPLETE THE PROCEDURE. THIS COMPLAINT IS REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: FAILURE ANALYSIS ACKNOWLEDGES THAT A FRAGMENT WAS MISSING FROM A PORTION OF THE DEVICE THAT ENTERS THE PATIENT (DISTAL END). 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, 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, POST-ANESTHESIA OF A DA VINCI-ASSISTED PROSTATECTOMY WITHOUT LYMPHADENECTOMY SURGICAL PROCEDURE, THE 30-DEGREE ENDOSCOPE PLUS HAD PHYSICAL DAMAGE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY NOR DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2909446 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-08 N/A 00886874116555

    Patients

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