BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3325630 · Received September 4, 2013

    Report

    Report Number
    2955842-2013-03368
    Event Type
    Injury
    Date Received
    September 4, 2013
    Date of Event
    August 1, 2013
    Report Date
    August 6, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K012833
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. BASED ON THE INFORMATION PROVIDED, THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. INTUITIVE SURGICAL INC. (ISI) HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE INITIAL REPORTER CLAIMED THAT THE PATIENT SUSTAINED A BURN NEXT TO A MARYLAND BIPOLAR FORCEPS INSTRUMENT DURING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, IT IS UNKNOWN HOW THE PATIENT'S INJURY OCCURRED. IT IS ALSO UNKNOWN IF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI SURGICAL PROCEDURE, THE SURGICAL STAFF INDICATED THAT THE PATIENT WAS BURNED IN A SMALL AREA NEXT TO A MARYLAND BIPOLAR FORCEPS INSTRUMENT. THE INITIAL REPORTER INDICATED THAT THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS INSTALLED ON PATIENT SIDE MANIPULATOR 2 (PSM2). THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. ON (B)(4) 2013, AN INTUITIVE SURGICAL INC. (ISI) FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND PERFORMED SYSTEM VERIFICATION. THE FSE ALSO PERFORMED AN ELECTRICAL SAFETY TEST AND NO OBSERVATIONS WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438492 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420171

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Life Threatening DA VINCI SI SURG SYS INST., ACCESSORIES, & ESU