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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. MONOPOLAR CURVED SCISSORS INSTSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

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INTUITIVE SURGICAL,INC. MONOPOLAR CURVED SCISSORS INSTSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT Back to Search Results
Model Number 420179-10
Event Date 10/22/2012
Event Type  Injury  
Event Description

It was reported that during a da vinci si hysterectomy procedure, the patient possibly sustained burns at the port site incisions were a monopolar curved scissors instrument and fenestrated bipolar forceps instrument were installed. In addition it was reported that the wire on the fenestrated bipolar forceps instrument was frayed. There were no missing or fallen pieces reported. Medwatch report 2955842-2012-01053 was submitted concerning the fenestrated bipolar forceps instrument.

 
Manufacturer Narrative

The instrument was returned and evaluated. Engineering was unable to confirm the customer reported failure mode. No sign of arcing was found at the clevis, nor the scissors of the instrument. The instrument was fully functional. On (b)(4) 2012 intuitive surgical contacted (b)(6) and she indicated the it is indeterminable if the damage to the patient's port site incisions were burns or a bruises. (b)(6) indicated that the circumference of the port sites were dark; however, the port sited did not exhibit any char marks. (b)(6) indicated that a valley lab force triad electrical surgical unit (esu) was used during the surgical procedure and there were no issues noted with the esu during the surgical procedure. (b)(6) indicated that monopolar curved scissors instrument was inspected prior to use and there was no damage to the instrument noted. (b)(6) indicated that there were no errors generated from the grounding pad used during the surgical procedure that indicated that it was defective. (b)(6) indicated that arcing during the surgical procedure was not observed; however, the monopolar curved scissors instrument made contact with a fenestrated bipolar forceps instrument that was also used during the surgical procedure, causing abrasions on one of the instruments. (b)(6) indicated that she is not sure which instrument was damaged. (b)(6) indicated that the planned surgical procedure was successfully completed and there were no intra-operative complications experienced by the patient. (b)(6) indicated that the port sites were excised and closed and to the best of her knowledge, the patient has not returned to the hospital due to experiencing any post-surgical complications as are result of the reported event. As of (b)(4) 2012, there have been no reported recurrences of the issue at this hospital.

 
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Brand NameMONOPOLAR CURVED SCISSORS INSTSTRUMENT
Type of DeviceENDOSCOPIC ELECTROSURGICAL INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL,INC.
sunnyvale CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC.,
1266 kifer rd, bldg 101
sunnyvale CA 9408 6
Manufacturer Contact
tabitha reed
1266 kifer rd, bldg 101
sunnyvale , CA 94086
MDR Report Key2843184
Report Number2955842-2012-01052
Device Sequence Number1
Product CodeNAY
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
Report Date 10/24/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/21/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number420179-10
Device LOT NumberM10120823 231
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/02/2012
Is The Reporter A Health Professional? No
Event Location Hospital
Date Manufacturer Received10/24/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2012
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 11/21/2012 Patient Sequence Number: 1
Treatment
DA VINCI SI SURG SYS, MCS TIP CVR, ACCES AND ESU
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