• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. DAVINCI STAPLER 45 ENDOWRIST STAPLER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INTUITIVE SURGICAL INC. DAVINCI STAPLER 45 ENDOWRIST STAPLER Back to Search Results
Model Number 470298
Device Problem Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/22/2018
Event Type  Malfunction  
Event Description

The jaws of the davinci stapler 45 locked and would not open after seating the instrument in the arm of the robot. In turn, the instrument was not recognized by the robot and could not be used for the remainder of the procedure. Instrument had 9 of 50 lives remaining. No harm to pt. To intuitive: (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDAVINCI STAPLER 45
Type of DeviceENDOWRIST STAPLER
Manufacturer (Section D)
INTUITIVE SURGICAL INC.
1266 kifer road, bldg 101
sunnyvale CA 94086 5304
MDR Report Key7572982
MDR Text Key110382700
Report NumberMW5077653
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 NumberT111802070029
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

-
-