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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. MONOPOLAR CURVED SCISSORS SYSTEM, SURGICAL COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. MONOPOLAR CURVED SCISSORS SYSTEM, SURGICAL COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 420179
Device Problems Crack (1135); Positioning Problem (3009)
Patient Problem No Information (3190)
Event Date 06/18/2018
Event Type  malfunction  
Event Description
Monopolar curved scissors had a small crack on bottom of instrument where orange label area is located. The instrument was unable to be seeded into cannula and defect was noted. (b)(4).
 
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Brand NameMONOPOLAR CURVED SCISSORS
Type of DeviceSYSTEM, SURGICAL COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road, bldg 101
sunnyvale CA 94086 5304
MDR Report Key7693352
MDR Text Key114293656
Report NumberMW5078424
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 Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number420179
Device Lot NumberN1080314 967
Was Device Available for Evaluation? Yes
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? No
Type of Device Usage

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