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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DAVINCI SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. DAVINCI SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Device Problems Use of Device Problem (1670); Output Problem (3005)
Patient Problem Insufficient Information (4580)
Event Date 03/12/2021
Event Type  malfunction  
Event Description
While using the davinci robot for a left inguinal hernia repair we had a non-recoverable fault occur, robotic surgery aborted, finished laparoscopically. Fda safety report id# (b)(4).
 
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Brand NameDAVINCI
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
MDR Report Key11700774
MDR Text Key246747526
Report NumberMW5100896
Device Sequence Number1
Product Code NAY
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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