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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER LIGASURE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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COVIDIEN MFG DC BOULDER LIGASURE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number LF1737
Medical Device Problem Code Energy Output Problem (1431)
Health Effect - Clinical Code No Information (3190)
Date of Event 05/14/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during laparoscopic radical resection of sigmoid colon adenocarcinoma, when the surgical closed cutter was used, the electrocoagulation was ineffective and the tissue at the cut site was bleeding.They used a dissector instead of cutting to stop bleeding.
 
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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 Key10401644
Report Number1717344-2020-00872
Device Sequence Number3094358
Product Code GEI
UDI-Device Identifier10884521181571
UDI-Public10884521181571
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K133338
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date04/10/2023
Device Model NumberLF1737
Device Catalogue NumberLF1737
Device Lot Number81010265X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/28/2020
Initial Report FDA Received Date08/13/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age78 YR
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