BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 8216188 · Received January 4, 2019

    Report

    Report Number
    2955842-2018-10807
    Event Type
    Injury
    Date Received
    January 4, 2019
    Date of Event
    December 11, 2018
    Report Date
    December 12, 2018
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE CURRENT INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE OF THE PATIENT¿S OPERATIVE COMPLICATION. IT IS UNCLEAR AS TO WHY THE SURGICAL STAFF ATTEMPTED TO USE THE MCS INSTRUMENT WITHOUT A MCS TIP COVER ACCESSORY INSTALLED. THE INSTRUMENT AND ACCESSORY MANUAL PROVIDES THE FOLLOWING WARNING: ¿WARNING: FAILURE TO INSTALL THE TIP COVER ACCESSORY PROPERLY MAY RESULT IN: IMPROPER SCISSOR OPENING. TIP COVER ACCESSORY FALLING OFF. ELECTRICAL ARCS AND ALTERNATE SITE BURNS. ISI HAS MADE FURTHER ATTEMPTS TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED. THE FOLLOWING INFORMATION IS UNKNOWN: THE DATE OF THE REPORTED EVENT, THE NAME OF THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE, THE LOCATION OF THE BURN INJURY, AND THE PART/LOT NUMBERS OF THE MCS INSTRUMENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED GYN PROCEDURE, THE PATIENT SUSTAINED A BURN INJURY THAT REQUIRED ADDITIONAL MEDICAL INTERVENTION. ALTHOUGH THERE IS EVIDENCE THAT THE MCS INSTRUMENT WAS MISUSED DURING THE CASE SINCE THE DEVICE WAS USED WITHOUT A MCS TIP COVER ACCESSORY INSTALLED, THE ROOT CAUSE OF THE INTRA-OPERATIVE COMPLICATION IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED GYN PROCEDURE, THE PATIENT SUSTAINED A BURN INJURY WHILE THE SURGICAL STAFF WAS USING A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. ACCORDING TO THE INITIAL REPORTER, THE SURGEON WAS USING THE MCS INSTRUMENT WITHOUT A MCS TIP COVER ACCESSORY INSTALLED. ACCORDING TO THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR), THE ORANGE AREA OF THE MCS INSTRUMENT WAS EXPOSED AND HAD TOUCHED THE PATIENT¿S ANATOMY. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. AT THIS TIME, THE ROOT CAUSE OF THE OPERATIVE COMPLICATION IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ON 12/14/2018, ISI CONTACTED A ROBOTICS COORDINATOR FROM THE SITE WHO WAS AWARE OF THE REPORTED EVENT. HE INDICATED THAT THE PATIENT REQUIRED ADDITIONAL UNSPECIFIED MEDICAL INTERVENTION AS A RESULT OF THE REPORTED BURN INJURY. THE ROBOTICS COORDINATOR DID NOT HAVE ADDITIONAL INFORMATION TO PROVIDE REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9892 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES