ENDOPATH XCEL OPTIVIEW 2CB5LT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-29 for ENDOPATH XCEL OPTIVIEW 2CB5LT manufactured by Ethicon Endo-surgery, Llc.

MAUDE Entry Details

Report Number9391779
MDR Report Key9391779
Date Received2019-11-29
Date of Report2019-11-20
Date of Event2019-08-12
Report Date2019-11-20
Date Reported to FDA2019-11-20
Date Reported to Mfgr2019-11-29
Date Added to Maude2019-11-29
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 NameENDOPATH XCEL OPTIVIEW
Generic NameLAPAROSCOPE, GENERAL PLASTIC SURGERY
Product CodeGCJ
Date Received2019-11-29
Model Number2CB5LT
Catalog Number2CB5LT
Lot NumberT40H1X
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerETHICON ENDO-SURGERY, LLC
Manufacturer Address475 CALLE C GUAYNABO PR 00969 US 00969


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-29

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