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 LIGASURE; ELECTROSURGICAL, CUTTING & COAGULATION & 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 LIGASURE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number LF1744
Medical Device Problem Code Energy Output To Patient Tissue Incorrect (1209)
Health Effect - Clinical Code Blood Loss (2597)
Date of Event 05/26/2018
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, post operatively, the patient had bleeding the same day as the procedure and the surgeon suspected it was from the sealed omentum.During a sleeve gastrectomy, the surgeon noted that the seal quality was not optimal with a bleed occurring just after a seal.The patient lost roughly a liter of blood which required a laparoscopic wash out and drain.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LIGASURE
Common Device Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
COVIDIEN MFG DC BOULDER
5920 longbow dr
boulder CO 80301 3299
MDR Report Key7607061
Report Number1717344-2018-00820
Device Sequence Number11186207
Product Code GEI
UDI-Device Identifier10884521181564
UDI-Public10884521181564
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K141153
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 06/15/2018
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 NumberLF1744
Device Catalogue NumberLF1744
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/31/2018
Initial Report FDA Received Date06/15/2018
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;
-
-