BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 10008031 · Received April 28, 2020

    Report

    Report Number
    2955842-2020-10376
    Event Type
    Malfunction
    Date Received
    April 28, 2020
    Date of Event
    February 21, 2018
    Report Date
    April 13, 2018
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112311
    PMA / PMN Number
    K131861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT AND PERFORMED A DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED AND REPLICATED THE REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE DISTAL CLEVIS, AND NOTED THERE WERE POTENTIAL SIGNS OF ARCING. THE MONOPOLAR YAW PULLEY WAS FOUND TO HAVE THERMAL DAMAGE AT THE DISTAL END LIKELY DUE TO AIR FIRING, AND POTENTIAL SIGNS OF ARCING WERE NOTED. THE DISTAL PART OF THE INSTRUMENT WAS TAKEN APART AND THE CONDUCTOR CAP WAS FOUND TO HAVE THERMAL DAMAGE, AND POTENTIAL SIGNS OF ARCING WERE NOTED. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE AT THE PROXIMAL CLEVIS, AND POTENTIAL SIGNS OF ARCING WERE NOTED. IT WAS FOUND THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT HAD 5 LIVES REMAINING. A LOG REVIEW WAS CONDUCTED, WHICH RESULTED IN THE FOLLOWING FINDINGS: IT WAS NOTED THE PERMANENT CAUTERY HOOK (PCH) (470183-11) N10170720-0039 WAS LAST USED ON (B)(6) 2018 ON A CHOLECYSTECTOMY PROCEDURE PERFORMED BY DR. (B)(6) WITH SYSTEM SK1352. AS OF 4/21/2020, 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 PROCEDURE VIDEO WAS PROVIDED BY THE SITE FOR REVIEW. THIS COMPLAINT IS BEING REPORTED BECAUSE THERMAL DAMAGE PROXIMAL TO THE CERAMIC SLEEVE IS EVIDENCE OF ELECTRICAL DISCHARGE AT A LOCATION OTHER THAN INTENDED. WHILE THERE WAS NO HARM OR INJURY TO PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION THAT ARE BLANK WERE EITHER UNKNOWN OR UNAVAILABLE. DEVICE EXPIRATION DATE WAS LEFT BLANK AS THIS INSTRUMENT HAS 10 USAGES ALLOTTED TO IT, WHICH ARE TRACKED BY THE DA VINCI SURGICAL SYSTEM. THIS REPORTED ISSUE OCCURRED ON THE INSTRUMENT'S 5TH USAGE AND, THEREFORE, HAD NOT EXPIRED. IMPLANT DATE IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. THIS REPORT HAS BEEN GENERATED IN RESPONSE TO FDA INSPECTIONAL OBSERVATIONS DATED 06-MAR-2020.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, A PERMANENT CAUTERY HOOK (PCH) INSTRUMENT HAD MELTED PLASTIC AROUND THE TIPS. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF PATIENT HARM, INJURY, OR ADVERSE OUTCOME. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ROBOTIC COORDINATOR WAS UNABLE TO PROVIDE FURTHER INFORMATION REGARDING THE REPORTED EVENT. IT WAS NOTED THE INSTRUMENT AND CANNULA WERE INSPECTED BEFORE USE, AND NOTHING OUT OF THE ORDINARY WAS OBSERVED. THE ROBOTICS COORDINATOR INFORMED THE INSTRUMENT WAS FOUND DAMAGED WHILE IT WAS IN USE. THE GENERATOR SETTINGS WERE SET TO 40 CUT AND 40 COAG. IT WAS STATED THE INSTRUMENT WAS IN USE FOR 5 MINUTES BEFORE THE REPORTED ISSUE. NO ARCING OR COLLISIONS WITH OTHER INSTRUMENTS WERE NOTED. THE ROBOTIC COORDINATOR STATED THERE WAS NO INJURY TO THE PATIENT, AND THE PATIENT HAS NOT RETURNED FOR ANY POST-SURGICAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467963 ENDOWRIST PERMANENT CAUTERY HOOK NAY INTUITIVE SURGICAL, INC 470183-11 N10170720 0039 00886874112311

    Patients

    Seq Age Sex Outcome Treatment
    1