LIGASURE LF1937

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-31 for LIGASURE LF1937 manufactured by Covidien Mfg Dc Boulder.

Event Text Entries

[186014016] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[186014017] According to the reporter, during anterior resection of rectum, after several activation of the device, the jaw opening and closing became not smooth. The knife did not return. The jaws could not be released unless force was applied to the front of the handle and so it was stopped using it. The device did not lock on tissue and was removed from the tissue without damaging it. Replaced with another similar device to complete the procedure. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5


[188674658] Evaluation summary: one device was received for evaluation. The returned product met specification as received. Visual inspection found no defects. The reported condition was not confirmed. The jaws opened and closed properly when the handle was retracted and released. The knife blade advanced and retracted smoothly along the knife track. The knife cut of the device was tested on a silicone test strip with acceptable results. The knife blade was also inspected under microscope and no issue was found. The investigation found the device to function normally and within specifications. The instructions for use (ifu) states, keep the instrument jaws clean. Build up of eschar may reduce sealing and/or cutting effectiveness. Wipe jaw surfaces and edges with a wet gauze pad as needed. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1717344-2020-00367
MDR Report Key9908551
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-11
Date Mfgr Received2020-03-11
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLISA HERNANDEZ
Manufacturer Street5920 LONGBOW DRIVE
Manufacturer CityBOULDER CO 80301
Manufacturer CountryUS
Manufacturer Postal80301
Manufacturer Phone2034925563
Manufacturer G1COVIDIEN MFG DC BOULDER
Manufacturer Street5920 LONGBOW DR
Manufacturer CityBOULDER CO 803013299
Manufacturer CountryUS
Manufacturer Postal Code803013299
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLIGASURE
Generic NameELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Product CodeGEI
Date Received2020-03-31
Model NumberLF1937
Catalog NumberLF1937
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN MFG DC BOULDER
Manufacturer Address5920 LONGBOW DR BOULDER CO 803013299 US 803013299


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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