• 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. DA VINCI XI MARYLAND BIPOLAR FORCEP 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. DA VINCI XI MARYLAND BIPOLAR FORCEP SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number XI
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem Insufficient Information (4580)
Event Type  No Answer Provided  
Event Description
This maryland bipolar xi instrument was returned to me with a blank fixt it tag. The tips of the instrument appear to be offset and a black cable is protruding. There was no indication from our logs that anything untoward occurred during the last documented case where this instrument was used. There were 4/10 lives remaining on the reposeable instrument. Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDA VINCI XI MARYLAND BIPOLAR FORCEP
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
MDR Report Key11207333
MDR Text Key228215439
Report NumberMW5098898
Device Sequence Number1
Product Code NAY
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 01/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberXI
Device Catalogue Number470172 VER14
Device Lot NumberN10170815
Was Device Available for Evaluation? Device Returned to Manufacturer
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

-
-