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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 Date 09/27/2012
Event Type  Injury  
Event Description

It was reported that during a da vinci s prostatectomy procedure, while the surgeon was performing pedicle dissection, arcing from the mcs tip cover accessory installed on the monopolar curved scissors instrument occurred causing unintentional burning. The mcs instrument was removed and inspection of the tip cover accessory by the surgical staff found that it had a crack at the wrist. The planned surgical procedure was completed using a replacement tip cover accessory. No other information concerning the patient was provided.

 
Manufacturer Narrative

The tip cover was returned and evaluated. Per the customer reported complaint, engineering observed that the tip cover has surface damage 0. 54 from the distal tip opening. The tip cover was found with a hole approximately 0. 03 in diameter and a slight burn mark was found on the inner wall of the tube. The hole opening on the outer wall is larger than the hole opening on the inner wall. On (b)(4) 2012, intuitive surgical contacted the initial reporter, (b)(6) (distributor). (b)(6) indicated that the burning as described in the initial report means that a spark was observed coming from the tip cover accessory. (b)(6) indicated that tissue was burned; however, it was minimal as the issue was identified early. (b)(6) indicated that repair of the affected area was not required as no perforation or bleeding occurred. (b)(6) indicated that a valley lab force fx was used and the coag setting was 50 watts (the mode was not provided). (b)(6) indicated that the mcs tip cover, mcs instrument and cannula were inspected prior to use and there were no abnormalities observed. Celeste indicated that a bipolar forceps instrument was also used during the surgical procedure; however, the mcs instrument did not make contact with bipolar forceps instrument. (b)(6) indicated that the mcs instrument was last used on (b)(6) 2012 and has been discarded and there is no video recording of the planned surgical procedure. (b)(6) indicated that the patient has not returned to the hospital due to experiencing any post-surgical complications. (b)(6) further indicated that she suspects that the damage to the tip cover occurred as a result of the surgeon's extreme manipulation of the mcs instrument during articulation. On july 12, 2012, intuitive surgical sent a product notification letter to the distributor (b)(6) advising them that a new version of the mcs tip cover (-12) is available. As of (b)(4) 2012, it is unknown why the site has continued to use the -10 version of the tip cover. Intuitive surgical has provided (b)(6) with a copy of the product notification letter that was sent on july 12, 2012.

 
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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
tabitha reed
1266 kifer rd, bldg 101
sunnyvale , CA 94086
MDR Report Key2836485
Report Number2955842-2012-00959
Device Sequence Number1
Product CodeNAY
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 10/19/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/16/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number400180-10
Device LOT NumberC11304
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/14/2012
Is The Reporter A Health Professional? No
Event Location Hospital
Date Manufacturer Received10/19/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 11/16/2012 Patient Sequence Number: 1
Treatment
DA VINCI S SURGICAL SYS, MCS INST, ACCESS & ESU
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