• 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. DAVINCIXL VESSEL SEALER EXTEND 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. DAVINCIXL VESSEL SEALER EXTEND SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Catalog Number REF 480422
Device Problem Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/16/2020
Event Type  malfunction  
Event Description
Surgeon noted gray material inside abdomen which was retrieved from body. Material appeared to be hard plastic. Vessel sealer noted to have a chipped tip on one of its jaws. Removed from field. Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDAVINCIXL VESSEL SEALER EXTEND
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL INC.
MDR Report Key11332135
MDR Text Key232193149
Report NumberMW5099380
Device Sequence Number1
Product Code NAY
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 02/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberREF 480422
Device Lot NumberM91201018
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? Yes
Type of Device Usage

-
-