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

Model Number 400180-10

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hemorrhage/Bleeding (1888); Thrombosis (2100); Tissue Damage (2104)

Event Type  Injury  

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.

Manufacturer Narrative

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

• Brand Name: 8MM MCS TIP COVER ACCESSORY
• Type of Device: ENDOSCOPIC 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 Key: 2874824
• MDR Text Key: 16539045
• Report Number: 2955842-2012-01314
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (Y/N): N
• PMA/PMN Number: K050005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional

Reporter Occupation

• 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 Received: 12/16/2012
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: 400180-10
• 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