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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
Event Type  Injury  
Event Description

On (b)(6) 2012, dr. (b)(6) at (b)(6) hospital in (b)(6) forwarded to intuitive surgical an article, titled robotic instrument insulation failure: initial report of a potential source of patient injury published by dr. (b)(6). The article alleges that from (b)(6) 2008 - (b)(6) 2009, 12 mcs tip cover accessories, installed on the monopolar curved scissors instruments failed intra-operatively during da vinci robotic procedures and with 3 of the tip cover failures resulting in patient injuries. The following details concerning the second patient injury as indicated in the article is as follows: during a da vinci urological procedure, while performing a retroperitoneal lymphadenectomy using the monopolar curved scissors instrument with the mcs tip cover installed, the patient's small bowel was injured. Damage to affected area was recognized immediately and was repaired by reapproximation of the serosa using a silk suture. Inspection of the tip cover accessory by the site found that the tip cover exhibited a hole at the junction of the silicon and gray plastic shaft on the tip cover. Per the information indicated in the report, the tip cover accessory was inspected prior to use, was installed on the mcs instrument using the tip cover installation tool with no obvious mechanical imperfections observed in the tip cover. No other details concerning the patient were provided. Medwatch report 2955842-2008-01353 was submitted to the fda concerning the first patient injury and medwatch report 2955842-2012-01412 was submitted for the third report of a 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.

 
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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 Key2884101
Report Number2955842-2012-01414
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 Received12/21/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number400180
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
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