BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3293195 · Received August 16, 2013

    Report

    Report Number
    2955842-2013-03068
    Event Type
    Malfunction
    Date Received
    August 16, 2013
    Date of Event
    July 19, 2013
    Report Date
    July 19, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION PERFORMED BY THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) FOUND NO ISSUES WITH THE HOSPITAL'S DA VINCI SURGICAL SYSTEM. FUNCTIONAL TESTING PERFORMED ON THE HOSPITAL'S SYSTEM BY THE FSE FOUND THAT THE HOSPITAL'S SYSTEM FUNCTIONED WITHIN SPECIFICATIONS. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION PROVIDED, ISI HAS CONCLUDED THAT THE HOSPITAL'S DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND ACCESSORIES DID NOT MALFUNCTION IN A WAY THAT CAUSED OR CONTRIBUTED TO THE PATIENT'S UTERUS BEING BURNED, BUT WAS RATHER CAUSED WHEN THE OR NURSE INADVERTENTLY CONNECTED THE BIPOLAR CORD FOR THE PRECISE BIPOLAR FORCEPS INSTRUMENT INTO THE INCORRECT RECEPTACLE ON THE ELECTROSURGICAL UNIT THAT WAS BEING USED DURING THE SURGICAL PROCEDURE. INTUITIVE SURGICAL'S INSTRUMENTS AND ACCESSORIES USER MANUAL PRECAUTIONS AND WARNINGS INDICATE: CAUTION: PLEASE REFER TO THE INDIVIDUAL ESU MANUFACTURER'S USER MANUAL FOR OPERATING INSTRUCTIONS. WARNING: DO NOT USE MONOPOLAR INSTRUMENTS WITH A BIPOLAR SOURCE OUTPUT AS THIS MAY CAUSE DAMAGE TO THE INSTRUMENT AND HARM TO THE PATIENT OR MEDICAL PERSONNEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THAT THE OR NURSE INADVERTENTLY INSTALLED THE BIPOLAR CORD FOR THE PRECISE BIPOLAR FORCEPS INSTRUMENT INTO THE MONOPOLAR RECEPTACLE ON THE SITE'S VALLEY LAB ELECTROSURGICAL UNIT (ESU), CAUSING THE PRECISE BIPOLAR FORCEPS INSTRUMENT TO ACTIVATE AND BURN THE PATIENT'S UTERUS, WHICH WAS BEING REMOVED AS PART OF THE SURGICAL PROCEDURE. THE PATIENT DID NOT SUSTAIN ANY OTHER INJURIES AND THE SITE WAS ABLE TO CORRECT THE ISSUE AND THE SURGICAL PROCEDURE WAS COMPLETED AS PLANNED. ON AUGUST 13TH, 2013, INTUITIVE SURGICAL CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT. THE INITIAL REPORTER INDICATED THAT AS A PRECAUTION THE HOSPITAL INSPECTED THEIR ESU. THEIR INVESTIGATION FOUND THAT THE ESU WAS FUNCTIONING PROPERLY. THE INITIAL REPORTER ALSO INDICATED THAT THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397873 PRECISE BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420110

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SURG INSTRUMENTS, ACCESSORIES & ESU