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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. FENESTRATED BIPOLAR FORCEPS SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. FENESTRATED BIPOLAR FORCEPS SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 470205
Device Problem Malposition of Device (2616)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/11/2020
Event Type  Injury  
Event Description
Fenestrated bipolar malfunction. After multiple attempts of troubleshooting bipolar the surgeon noticed a single piece of cable sticking out of the jaws of the instrument. The instrument would not release after several attempts of troubleshooting this new issue. Eventually we learned the metal portion of the instrument was lifting away from the shaft alerting the davinci of an obstruction. The surgeon was able to safely remove the instrument and its entirety along with the metal trocar. Fda safety report id# (b)(4).
 
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Brand NameFENESTRATED BIPOLAR FORCEPS
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
MDR Report Key10055852
MDR Text Key191115189
Report NumberMW5094492
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 Biomedical Engineer
Type of Report Initial
Report Date 05/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470205
Device Catalogue Number470205
Device Lot NumberN11190806 0061
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

Patient Treatment Data
Date Received: 05/13/2020 Patient Sequence Number: 1
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