• 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 400272
Device Problems Thermal Decomposition of Device (1071); Detachment Of Device Component (1104); Fire (1245); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/14/2017
Event Type  malfunction  
Event Description
Harmonic ace curved shears incert , ref# (b)(4), lot: m10170717, exp: 07/31/2019. A warning came across the harmonic machine that said release pressure on jaws then the jaws started on fire and burned on half of the jaws. The jaws where not in connection to any tissue at the time of event and the jaws were open. Essentially there was no pressure on the jaws. Instrument was removed from the pt as well as the jaw piece that burned off. Packaging and pieces retained and given to manager. Ultimately there was no patient harm.
 
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 Key7266311
MDR Text Key99948391
Report Number7266311
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 01/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Model Number400272
Device Catalogue Number400272
Device Lot NumberM10170717
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/15/2018
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer01/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-