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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 LF1537
Medical Device Problem Codes Mechanical Problem (1384); Retraction Problem (1536); Difficult to Open or Close (2921)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/15/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Evaluation summary: to date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
 
Event or Problem Description
According to the reporter, the device control grip had problems opening and closing.The knife additionally cannot advance and retract normally.There was no patient injury.
 
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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 Key7105128
Report Number1717344-2017-06359
Device Sequence Number16509197
Product Code GEI
UDI-Device Identifier20884524002290
UDI-Public20884524002290
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K092879
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 12/11/2017
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 Date05/01/2020
Device Model NumberLF1537
Device Catalogue NumberLF1537
Device Lot Number50850206X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/15/2017
Initial Report FDA Received Date12/11/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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