BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 9873745 · Received March 24, 2020

    Report

    Report Number
    2955842-2020-10216
    Event Type
    Injury
    Date Received
    March 24, 2020
    Date of Event
    February 28, 2020
    Report Date
    February 28, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K173337
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NEW OR UPDATED INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: PATIENT RACE, PATIENT ETHNICITY, G7, H2, H10. THE VESSEL SEALER EXTEND INSTRUMENT CAPTURED ON THIS COMPLAINT WAS DISPOSED AND WILL NOT BE RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. THEREFORE, FAILURE ANALYSIS COULD NOT BE PERFORMED. ISI INVESTIGATED THE RETURNED FRAGMENT RETURNED UNDER PATIENT IDENTIFIER 201487. THE FRAGMENT WAS IDENTIFIED TO BE A PIECE OF A CONDUCTOR WIRE INSULATION MEASURING APPROXIMATELY 0.151" IN LENGTH. WITHOUT A PHYSICAL INVESTIGATION OF THIS INSTRUMENT, A DIRECT CORRELATION OF THE RETURNED FRAGMENT WITH THE INSTRUMENT REFERENCED UNDER THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. REVIEW OF THE SYSTEM AND INSTRUMENT LOGS CONFIRMED THE CUSTOMER THE USAGE OF MONOPOLAR CURVED SCISSORS (MCS), VESSEL SEALER EXTEND (VSE), LONG BIPOLAR GRASPER, LARGE NEEDLE DRIVER INSTRUMENTS ON DA VINCI SYSTEM SK2281 ON THE REPORTED EVENT DATE. THE INSTRUMENT REFERENCED IN THIS COMPLAINT HAS NOT BEEN USED IN SUBSEQUENT PROCEDURE SINCE ITS LAST USAGE ON THE REPORTED EVENT DATE.

    Additional Manufacturer Narrative · 0

    BASED ON A RE-EVALUATION OF THE COMPLAINT INFORMATION, THIS COMPLAINT HAS BEEN RECLASSIFIED AS AN ADVERSE EVENT AND PRODUCT PROBLEM RATHER THAN JUST A PRODUCT PROBLEM, AS PREVIOUSLY REPORTED. CORRECTED INFORMATION CAN BE FOUND THE FOLLOWING FIELD: B1, B2, AND H1 B1 UPDATED FROM "PRODUCT PROBLEM" TO "ADVERSE EVENT AND PRODUCT PROBLEM" B2 UPDATED TO "REQUIRED INTERVENTION". H1 UPDATED FROM "MALFUNCTION" TO "SERIOUS INJURY".

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    A PHOTOGRAPH OF THE RETRIEVED FRAGMENT WAS RECEIVED FROM THE CUSTOMER. A REVIEW OF THE SUBMITTED PHOTOGRAPH WAS PERFORMED BY THE INTUITIVE SURGICAL, INC. (ISI) QUALITY INVESTIGATIONS ENGINEER (QIE). THE QIE WAS UNABLE TO MAKE A CONCLUSIVE DETERMINATION OF THE ALLEGED FRAGMENT BASED ON THE PHOTOGRAPH, AND WHETHER IT WAS FROM AN ISI PRODUCT. AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE REFERENCED 0 DEGREE ENDOSCOPE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. INVESTIGATION IDENTIFIED NO ISSUE AND NO MISSING FRAGMENTS. THE ENDOSCOPE WAS VERIFIED AS READY FOR USE. ISI HAS NOT RECEIVED THE INSTRUMENTS OR THE FRAGMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT OR THE FRAGMENT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A FRAGMENT WAS FOUND INSIDE THE PATIENT. ALTHOUGH THE FRAGMENT WAS RETRIEVED WITHOUT PATIENT HARM, ADVERSE OUTCOME OR INJURY, THIS EVENT COULD POTENTIALLY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. AT THE TIME OF THIS REPORT, THE SOURCE OF THE FRAGMENT REMAINS UNKNOWN, INCLUDING WHETHER THE FRAGMENT CAME FROM AN ISI PRODUCT OR FROM SOME OTHER SOURCE. DUE TO THE POTENTIAL OF THE FRAGMENT COMING FROM AN ISI PRODUCT, REFER TO THE FOLLOWING REPORTS BEING SUBMITTED: PATIENT IDENTIFIER (B)(6) FOR THE REPORT ON THE MONOPOLAR CURVED SCISSORS INSTRUMENT PATIENT IDENTIFIER (B)(6) FOR THE INVESTIGATION OF THE RETURNING LONG BIPOLAR GRASPER INSTRUMENT PATIENT IDENTIFIER (B)(6) FOR THE INVESTIGATION OF THE RETURNING LARGE NEEDLE DRIVER INSTRUMENT PATIENT IDENTIFIER (B)(6) FOR THE INVESTIGATION OF THE VESSEL SEALER EXTEND INSTRUMENT BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE INFORMATION WAS EITHER UNKNOWN OR UNAVAILABLE. THE SECTIONS THAT ARE NOT APPLICABLE TO THIS PRODUCT ARE BLANK. THE PRODUCT IS NOT IMPLANTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL HYSTERECTOMY PROCEDURE, THE SURGEON VISUALIZED A FRAGMENT INSIDE THE PATIENT'S BODY. THE ENTIRE FRAGMENT WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUE. THERE WAS NO REPORT OF INSTRUMENT COLLISION, PATIENT HARM, ADVERSE OUTCOME OR INJURY. ACCORDING TO THE REPORTER, THEY WERE UNABLE TO DETERMINE THE SOURCE OF THE FRAGMENT. THE CUSTOMER REPORTED THAT THEY WERE NOT SURE IF THE FRAGMENT CAME FROM AN INTUITIVE SURGICAL INC. (ISI) INSTRUMENT/ACCESSORY, OR FROM SOME OTHER SOURCE. THE CUSTOMER NOTED THAT THEY WERE USING THE FOLLOWING ISI PRODUCTS DURING THE PROCEDURE: MONOPOLAR CURVED SCISSORS (MCS), VESSEL SEALER EXTEND (VSE), LONG BIPOLAR GRASPER, LARGE NEEDLE DRIVER INSTRUMENT, AND 0 DEGREE ENDOSCOPE. ISI FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: NO KNOWN POST-OPERATIVE TESTS (X-RAY, ULTRA SOUND) WERE PERFORMED AND NO KNOWN ADDITIONAL SURGICAL INTERVENTION WAS CONDUCTED. NO POST-OPERATIVE COMPLICATIONS HAVE BEEN REPORTED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337231 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 M90191014

    Patients

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