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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 LF1837
Device Problem Energy Output Problem (1431)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/02/2023
Event Type  malfunction  
Manufacturer Narrative
D10 concomitant product: blunt tip sealer divider lf1837 (lot#: 23210236x); blunt tip sealer divider lf1837 (lot#: 23210236x).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Event Description
According to the reporter, during a procedure, the device was plugged into a generator, the tip cut but it did not seal.Activation and end tone was heard but sealing was inadequate/partial.Surgeon decided to change the device, but still the same.So, another device was provided again, but still the same.Surgeon decided to change device brand.Another ligasure device used successfully with this generator.There was no patient injury.
 
Manufacturer Narrative
Changed aware date to 09-jul-23 instead of 30-jun-23.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
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Brand Name
LIGASURE
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
COVIDIEN MFG DC BOULDER
5920 longbow dr
boulder CO 80301 3299
Manufacturer (Section G)
COVIDIEN MFG DC BOULDER
5920 longbow dr
boulder CO 80301 3299
Manufacturer Contact
justin ellis
8200 coral sea st ne
mounds view, MN 55112
7635265677
MDR Report Key19182066
MDR Text Key341703054
Report Number1717344-2024-01051
Device Sequence Number1
Product Code GEI
UDI-Device Identifier10884521705883
UDI-Public10884521705883
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K162941
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/22/2024
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
Device Operator Health Professional
Device Model NumberLF1837
Device Catalogue NumberLF1837
Device Lot Number23210236X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/30/2023
Initial Date FDA Received04/25/2024
Supplement Dates Manufacturer Received05/16/2024
Supplement Dates FDA Received05/22/2024
Date Device Manufactured11/17/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
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