ENSEAL NSLG2S45A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-31 for ENSEAL NSLG2S45A manufactured by Ethicon Endo-surgery, Inc.

Event Text Entries

[185707123] Enseal device began peeling while in use during laparoscopic procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9902818
MDR Report Key9902818
Date Received2020-03-31
Date of Report2018-11-19
Date of Event2018-10-11
Report Date2020-03-18
Date Reported to FDA2020-03-18
Date Reported to Mfgr2020-03-31
Date Added to Maude2020-03-31
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENSEAL
Generic NameELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
Product CodeGEI
Date Received2020-03-31
Model NumberNSLG2S45A
Catalog NumberNSLG2S45A
Lot NumberR9319L
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerETHICON ENDO-SURGERY, INC
Manufacturer Address4545 CREEK ROAD CINCINNATI OH 45242 US 45242


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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