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

Model Number 400180-10

Device Problem Sparking (2595)

Patient Problems Burn, Thermal (2530); Blood Loss (2597)

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. (b)(6). 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 third patient injury as alleged in the article: during a da vinci hysterectomy procedure, a (b)(6) woman with stage ib1 cervical cancer was undergoing robotic-assisted radical hysterectomy, bilateral salpingectomy, pelvic lymph node dissection, and para-aortic lymph node sampling using the robotic surgical platform system. During lymphadenectomy, activation of monopolar coagulation-type current, set at 35 w, caused a spark to extrude laterally through the scissors insulating plastic sheath and onto the right external iliac artery. The surface of the vessel was visibly charred, and a defect was noted in the tunica media of the vessel. Because of concern for delayed necrosis, the area was oversewn with a 4. 0 prolene stitch; estimated blood loss was 100 ml. The patient was discharged from the hospital on the third postoperative day because of unrelated respiratory issues requiring nebulizer treatments and chest physical therapy. She did not encounter further complications or sequelae. Medwatch report 2955842-2012-01314 and 2955842-2012-01406 were submitted for the first and second 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: 2884094
• MDR Text Key: 3105031
• Report Number: 2955842-2012-01405
• 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: 12/21/2012
• 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: 12/21/2012 Patient Sequence Number: 1

Treatment

DAVINCI S SURG SYSTEM, INSTRUMENT AND ACCESSORIES