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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL UNIT DAVINCI SI VESSEL SEALER SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number SI
Device Problem Stretched (1601)
Patient Problem No Information (3190)
Event Date 04/24/2019
Event Type  malfunction  
Event Description
Da vinci si vessel sealer, first instrument staff identified "stretched" energy cable at the distal end of instrument. Removed from sterile field and replaced.
 
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Brand NameDAVINCI SI VESSEL SEALER
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL UNIT
950 kifer road
sunnyvale CA 94086
MDR Report Key8600333
MDR Text Key144873389
Report NumberMW5086534
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 Other Health Care Professional
Type of Report Initial
Report Date 05/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSI
Device Catalogue Number410322-05
Device Lot NumberM11181014
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2019
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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