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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC. CAUTERY SPATULA SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem Insufficient Information (4580)
Event Date 04/19/2021
Event Type  malfunction  
Event Description
Da vinci cautery spatula inserted into port site of patient. Md noticed wires sticking out by the tip of the cautery spatula. Da vinci instrument removed from patient and from sterile field. Service coordinator made aware.
 
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Brand NameCAUTERY SPATULA
Type of DeviceSYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key12165606
MDR Text Key261473491
Report Number12165606
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 07/09/2021,04/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/09/2021
Event Location Hospital
Date Report to Manufacturer07/14/2021
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 Unkown

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