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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL INC. PERMANENT CAUTERY SPATULA DAVINCI; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 420184
Device Problem Material Discolored (1170)
Patient Problem Insufficient Information (4580)
Event Date 05/03/2021
Event Type  malfunction  
Event Description
Insulation on pivoting portion of the davinci spatula instrument head had blackened during use.When the device was removed it had a charcoal like appearance.Fda safety report id # (b)(4).
 
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Brand Name
PERMANENT CAUTERY SPATULA DAVINCI
Type of Device
SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL INC.
sunnyvale CA 94086
MDR Report Key11783037
MDR Text Key249494651
Report NumberMW5101192
Device Sequence Number1
Product Code NAY
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number420184
Device Catalogue Number420184
Device Lot NumberN10190212
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/05/2021
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age63 YR
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