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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL VESSEL SEALER EXTEND DAVINCI VESSEL SEALER SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL VESSEL SEALER EXTEND DAVINCI VESSEL SEALER SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 480422
Device Problems Difficult to Remove (1528); Difficult to Open or Close (2921)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/09/2019
Event Type  malfunction  
Event Description
Intuitive surgical, davinci, vessel sealer extend was very difficult to open and remove from tissue following its firing. Fda safety report id # (b)(4).
 
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Brand NameVESSEL SEALER EXTEND DAVINCI VESSEL SEALER
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL
sunnyvale CA 94086
MDR Report Key8790496
MDR Text Key151321742
Report NumberMW5088089
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
Type of Report Initial
Report Date 07/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Model Number480422
Device Catalogue Number480422
Device Lot NumberL10190303
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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