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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 LF1937
Device Problem Energy Output Problem (1431)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 02/21/2024
Event Type  malfunction  
Manufacturer Narrative
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 laparoscopic kidney removal using a device plugged into a generator, around 30 minutes into the surgery, it was noticed that the device had a suboptimal performance, with increased bleeding at the closure site.There was an activation and end tone, but sealing was inadequate/partial.The seal seemed adequate but bleeds after cutting and it was observed directly from the seal and the vessel was fully transected.Another same device was used.
 
Manufacturer Narrative
Additional information: b5, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the sealing was inadequate.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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 laparoscopic kidney removal using a device plugged into a generator, around 30 minutes into the surgery, it was noticed that the device had a suboptimal performance, with increased bleeding at the closure site with the tissues around the kidney.There was an activation and end tone, but sealing was inadequate/partial.The seal seemed adequate but bleeds after cutting and it was observed directly from the seal and the vessel was fully transected.Blood transfusion was not required.There was no displayed alarms or error icons, and no thickness warning displayed.The device was also cleaned 2-3 times within 30 minutes.Another same device was used.
 
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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 Key18944419
MDR Text Key338711349
Report Number1717344-2024-00778
Device Sequence Number1
Product Code GEI
UDI-Device Identifier10884521705913
UDI-Public10884521705913
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K170869
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLF1937
Device Catalogue NumberLF1937
Device Lot Number32980315X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/22/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/25/2023
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 Age62 YR
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