• 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. INTUITIVE SURGICAL DAVINCI XI HOT SHEARS DA VINCI XI HOT SHEARS

  • 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. INTUITIVE SURGICAL DAVINCI XI HOT SHEARS DA VINCI XI HOT SHEARS Back to Search Results
Catalog Number 470179-14
Device Problem Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/29/2018
Event Type  malfunction  
Event Description
Distal shaft on hot shear instrument "cracked" while installing instrument sheath. Did not reach pt. No harm.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINTUITIVE SURGICAL DAVINCI XI HOT SHEARS
Type of DeviceDA VINCI XI HOT SHEARS
Manufacturer (Section D)
INTUITIVE SURGICAL INC.
950 kifer road
sunnyvale CA 94086
MDR Report Key7302365
MDR Text Key101286491
Report NumberMW5075560
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 Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number470179-14
Device Lot NumberN11170911-0064
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2018
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

-
-