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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DAVINCI STAPLER

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INTUITIVE SURGICAL, INC. DAVINCI STAPLER Back to Search Results
Model Number DAVINCI XI STAPLER
Device Problems Failure to Calibrate (2440); Failure to Fire (2610)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/01/2018
Event Type  malfunction  
Event Description
Davinci xi stapler would not calibrate or fire.
 
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Brand NameDAVINCI
Type of DeviceSTAPLER
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1090 kifer rd.
sunnyvale CA 94086
MDR Report Key8503244
MDR Text Key141591141
Report Number8503244
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 Risk Manager
Type of Report Initial
Report Date 03/29/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDAVINCI XI STAPLER
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/29/2019
Event Location Hospital
Date Report to Manufacturer04/11/2019
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

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