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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. 8MM MCS TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY

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INTUITIVE SURGICAL,INC. 8MM MCS TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY Back to Search Results
Model Number 400180-10
Event Type  Injury  
Manufacturer Narrative

Isi has contacted the initial reporter concerning the reported event. A follow-up mdr will be submitted if additional information is provided.

 
Event Description

On (b)(6) 2012, dr (b)(6) provided the article titled electrocautery-associated vascular injury during robotic-assisted surgery published by dr. Beatrice cormier, farr nezhat, jason sternchos, yukio sonoda, and mario leitao. The article alleges that the mcs tip cover accessory, installed on the monopolar curved scissors instruments failed intra-operatively during da vinci robotic procedures. Three of the tip cover accessory failures were alleged to have resulted in patient injuries. The following details are related to the first patient injury as alleged in the article: during a da vinci hysterectomy procedure, a (b)(6) woman with a body mass index of (b)(6) was undergoing robotic-assisted hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymph node dissection for endometrial cancer using the robotic surgical platform system. During retrieval of the right obturator lymph nodes, cutting-type current set at 35 w sparked through the intact protective sheath of the monopolar scissors onto an adjacent metallic suction irrigator that was retracting the external iliac vein. Conduction through the suction irrigator resulted in a vessel injury. After robotic suturing and attempted clipping of the defect was unsuccessful, the patient required emergency laparotomy with external iliac vein ligation. Estimated blood loss was 2,000 ml, and she received 2 units of packed red blood cells. Postoperatively, she was administered prophylactic enoxaparin 40 mg daily initially but required full anticoagulation after right lower extremity venous thrombosis was confirmed. She was discharged home on postoperative day 10 without any further sequelae. At 6-month follow-up, she was without evidence of disease and did not have any leg edema. Medwatch report were submitted for the second and third reports of patient injury.

 
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Brand Name8MM MCS TIP COVER ACCESSORY
Type of DeviceENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY
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
jane clay
1266 kifer rd, bldg 101
sunnyvale , CA 94086
MDR Report Key2874824
Report Number2955842-2012-01314
Device Sequence Number1
Product CodeNAY
Report Source Manufacturer
Source Type Literature,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 08/02/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/16/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number400180-10
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Hospital
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 12/16/2012 Patient Sequence Number: 1
Treatment
DAVINCI S SURG SYSTEM, INSTRUMENT AND ACCESSORIES
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