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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DA VINCI VESSEL SEALER SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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DA VINCI VESSEL SEALER SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 410322
Device Problem Use of Device Problem (1670)
Patient Problem Failure to Anastomose (1028)
Event Date 10/30/2018
Event Type  Injury  
Event Description
Da vinci vessel sealer used but failed. Rn tried to trouble shoot, but failed. A new set was opened, installed and it also failed. The failure was the device would not seal off a bleeder. Due to this, the provider had to convert the procedure from the robotic assisted hysterectomy to the open hysterectomy. Intuitive surgical.
 
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Brand NameDA VINCI VESSEL SEALER
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
MDR Report Key8070843
MDR Text Key127352471
Report NumberMW5081248
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 11/06/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received11/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Model Number410322
Device Lot NumberM00080706
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? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 11/13/2018 Patient Sequence Number: 1
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