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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DAVINCI XI SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. DAVINCI XI SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Catalog Number 372601-20
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 04/08/2021
Event Type  malfunction  
Event Description
Endoscope controller failed intra-operatively.
 
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Brand NameDAVINCI XI
Type of DeviceSYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key12646789
MDR Text Key276919169
Report Number12646789
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/29/2021,09/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number372601-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/29/2021
Device Age9 MO
Event Location Hospital
Date Report to Manufacturer10/18/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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