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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. SCISSOR, MONOPOLAR

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INTUITIVE SURGICAL, INC. SCISSOR, MONOPOLAR Back to Search Results
Device Problem Use of Device Problem (1670)
Patient Problem No Information (3190)
Event Date 07/16/2018
Event Type  malfunction  
Event Description
The device would not work when tested. A new device was obtained and the procedure continued without incident. The device was placed in the recycle bin and is no longer in the organization.
 
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Type of DeviceSCISSOR, MONOPOLAR
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer rd
sunnyvale CA 94086
MDR Report Key7858758
MDR Text Key119661029
Report Number7858758
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/20/2018
Event Location No Information
Date Report to Manufacturer09/04/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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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