BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST;DAVINCI SI

    MDR report key: 16481033 · Received March 3, 2023

    Report

    Report Number
    2955842-2023-11048
    Event Type
    Injury
    Date Received
    March 3, 2023
    Date of Event
    January 30, 2023
    Report Date
    February 6, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874111475
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION RESULTING IN THE CONVERSION TO AN OPEN SURGICAL PROCEDURE CANNOT BE DETERMINED. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED FOR THE INSTRUMENT INVOLVED IN THIS EVENT, BUT IT HAD NOT BEEN RECEIVED BY INTUITIVE SURGICAL, INC. (ISI) BY THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED. AN ADVANCED SYSTEM LOG REVIEW COULD NOT BE REQUESTED AT THIS TIME DUE TO INSUFFICIENT INFORMATION. THE PROVIDED PROCEDURE INFORMATION DID NOT MATCH THE REPORTED INSTRUMENT DATA; HENCE THE EVENT DATE, THE PROCEDURE, AND THE SYSTEM CANNOT BE ADEQUATELY VERIFIED, AND A REVIEW OF THE SYSTEM LOGS COULD NOT BE PERFORMED. THIS IS CONSIDERED A REPORTABLE ADVERSE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT DURING A DAVINCI-ASSISTED GENERAL SURGICAL PROCEDURE, A VASCULAR INJURY OCCURRED, POSSIBLY DUE TO CONTACT WITH THE TIP OF THE FORCEPS DURING THE PROCEDURE. THE PROCEDURE WAS REPORTEDLY CONVERTED TO OPEN, AND IT WAS SUCCESSFULLY COMPLETED. PER THE SURGEON, THE INJURY WAS NOT DUE TO A MALFUNCTION OF THE SYSTEM OR THE INSTRUMENT.

    Additional Manufacturer Narrative · 0

    ON 12-APR-2023, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE SURGEON REGARDING THE REPORTED EVENT: AT THE TIME THE COMPLICATION OCCURRED, THE SURGEON WAS STRIPPING/DISSECTING TISSUE. IT WAS UNKNOWN WHICH TISSUE AND/OR VESSELS WERE DAMAGED. WHILE BLEEDING DID OCCUR AND HEMOSTASIS WAS EVENTUALLY ACHIEVED, THE AMOUNT OF BLEEDING WAS UNKNOWN, AND NO BLOOD TRANSFUSIONS WERE REQUIRED. NO ANATOMICAL FACTORS CONTRIBUTED TO THE BLEEDING. THE MEDICAL INTERVENTION TAKEN TO RESOLVE THE BLEEDING WAS A CONVERSION TO LAPAROTOMY, WHICH RESOLVED THE ISSUE. THE CAUSE OF THE DAMAGE TO THE BLOOD VESSEL WAS UNKNOWN, AND THIS COMPLICATION WAS UNEXPECTED AS A PART OF THE PROCEDURE. PER THE SURGEON, THE COMPLICATION DID NOT IMPACT THE PATIENT'S HEALTH, NO POSTOPERATIVE COMPLICATIONS OCCURRED, AND NO LONG-TERM COMPLICATIONS ARE EXPECTED. THE PATIENT HAS SINCE BEEN DISCHARGED. THE DA VINCI SYSTEM, INSTRUMENTS, AND/OR ACCESSORIES DID NOT CAUSE OR CONTRIBUTE TO THE COMPLICATION, NOR DID THEY MALFUNCTION IN ANY WAY. NO UNINTUITIVE MOTION OF ANY INSTRUMENTS OR OTHER DEVICES OCCURRED DURING THE PROCEDURE. BECAUSE NO PRODUCT DEFECT WAS IDENTIFIED, THE INSTRUMENT WAS RE-STERILIZED AT THE FACILITY AND PUT BACK INTO ROTATION FOR USE. THE SYSTEM AND INSTRUMENTS WERE INSPECTED PRIOR TO USE, AND NO ABNORMALITIES WERE FOUND. THE CUSTOMER STATED THAT THE INSTRUMENT WILL NOT BE RETURNED. PER A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE CONFIRMED PROCEDURE DATE, NO RELATED SYSTEM ERRORS OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. BASED ON THE CONFIRMATION OF PROCEDURE DETAILS FROM THE SITE, THE INSTRUMENT PART NUMBER AND LOT NUMBER HAVE BEEN UPDATED. THE INSTRUMENT INITIALLY REPORTED WAS NOT USED DURING THIS PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DAVINCI-ASSISTED GENERAL SURGICAL PROCEDURE, A VASCULAR INJURY OCCURRED, POSSIBLY DUE TO CONTACT WITH THE TIP OF THE MARYLAND BIPOLAR FORCEPS DURING THE PROCEDURE. THE PROCEDURE WAS REPORTEDLY CONVERTED TO OPEN, AND IT WAS SUCCESSFULLY COMPLETED. PER THE SURGEON, THE INJURY WAS NOT DUE TO A MALFUNCTION OF THE SYSTEM OR THE INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER CONCERNING THE REPORTED EVENT WITH NO RESPONSE AT THE TIME OF THIS REPORT. THE CAUSE AND SEVERITY OF THE INJURY, THE VESSEL INJURED, ANY MEDICAL INTERVENTION(S), THE PATIENT'S CURRENT STATUS, AND ANY ADDITIONAL DETAILS ARE CURRENTLY UNKNOWN. THE PROCEDURE DETAILS WERE UNCONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1932302 ENDOWRIST;DAVINCI SI MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 420172-17 N10211027 142 00886874111475

    Patients

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