• 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. ENDOWRIST SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

  • 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. ENDOWRIST SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 470179
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/05/2020
Event Type  malfunction  
Event Description
Patient was brought to the operating room. General anesthesia was given and he was intubated. Procedure started and when it was time to use the scissors, they could not get it to work. Scissors was changed and the procedure continued and was completed without any further incident. No harm done. Manufacturer response for system, surgical, computer controlled instrument, endowrist (per site reporter). Surgery robotic coordinator reported this to company and device was sent to materials management per facility protocol. Spoke to surgical coordinator in materials management and she is planning to send back the device within two weeks.
 
Event Description
Patient was brought to the operating room. General anesthesia was given and he was intubated. Procedure started and when it was time to use the scissors, they could not get it to work. Scissors was not recognized by the system prior to malfunctioning. Scissors was changed and the procedure continued and was completed without any further incident. No harm done.
======================
manufacturer response for system,surgical,computer controlled instrument, endowrist (per site reporter)
======================
surgery robotic coordinator reported this to company and device was sent to materials management per facility protocol. Spoke to surgical coordinator in materials management and she is planning to send back the device within two weeks.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameENDOWRIST
Type of DeviceSYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key10331942
MDR Text Key200611199
Report Number10331942
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,Followup
Report Date 07/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/28/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470179
Device Lot NumberN11200427
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/01/2020
Event Location Hospital
Date Report to Manufacturer07/28/2020
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?
Type of Device Usage

-
-