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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 470298
Device Problems Failure to Calibrate (2440); Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/03/2018
Event Type  Malfunction  
Event Description

The davinci stapler would not calibrate appropriately - only to 35%. The jaws would not open. No harm to pt. To intuitive: (b)(4).

 
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Brand NameDAVINCI STAPLER
Type of DeviceDAVINCI STAPLER
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road, bldg 101
sunnyvale CA 94086 5304
MDR Report Key7572981
MDR Text Key110357502
Report NumberMW5077652
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 05/30/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/05/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number470298
Device LOT NumberT11180207
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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