Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER EMPRINT; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
  • 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
 

COVIDIEN MFG DC BOULDER EMPRINT; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES Back to Search Results
Model Number CA15L2
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Codes No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event 10/05/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, after the withaferin a (wfa) for liver cancer, the activation was completed and the blue cable extending from the antenna was quite hot.The doctor felt that it could cause burn injury if it contacted a patient for a long time.The activation was "45w for 1 minute, 55w for 1 minute, 65w for 1 minute, 75w for 1 minute, 100w for 5 minutes".Post-operatively, the patient received 4 units of blood transfusion.It was noted that the patient had a blood platelet of below 50,000 and hemoglobin dropped to 4.A 10kg of ascitic fluid was pooled, and it was drained.Patient's condition was currently fine.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EMPRINT
Common Device Name
SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
Manufacturer (Section D)
COVIDIEN MFG DC BOULDER
5920 longbow dr
boulder CO 80301 3299
MDR Report Key8051332
Report Number1717344-2018-01461
Device Sequence Number11209325
Product Code NEY
UDI-Device Identifier10884521706583
UDI-Public10884521706583
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K163105
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberCA15L2
Device Catalogue NumberCA15L2
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/15/2018
Initial Report FDA Received Date11/08/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
-
-