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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST SYSTEM, SURGICAL, COMPUTER

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INTUITIVE SURGICAL, INC. ENDOWRIST SYSTEM, SURGICAL, COMPUTER Back to Search Results
Catalog Number 470205
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/18/2018
Event Type  malfunction  
Event Description
While performing a robotic low anterior colon resection with doctor, it was noticed that the tip of a robotic fenestrated bipolar forceps had broken off. The broken instrument was immediately removed and it was written on the board that a tip was missing. X-ray was called as the surgery was ending, but was then cancelled as the surgeon manually found and removed the broken tip. These devices can be reused ten times. This was the 10th time for this particular device.
 
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Brand NameENDOWRIST
Type of DeviceSYSTEM, SURGICAL, COMPUTER
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1450 kifer rd.
sunnyvale CA 94086
MDR Report Key7263139
MDR Text Key99800693
Report Number7263139
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 01/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number470205
Device Lot NumberN11170908 0147
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/30/2018
Event Location Hospital
Date Report to Manufacturer01/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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