XCEL * B15LT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-27 for XCEL * B15LT manufactured by Ethicon Endo-surgery, Inc..

Event Text Entries

[21965659] During laparoscopic gastric bypass surgery, the surgeon reports two trocar ports leaking, resulting in decrease insufflation of abdomen. The 15mm bladeless ethicon trocar (ref # b15lt, lot # k4cz72) is new while 5mm bladeless ethicon trocar (lot # 2503719 ref# cb5lt) is reprocessed. Both devices continue to be used. Unable to sequester at this time.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number3359415
MDR Report Key3359415
Date Received2013-08-27
Date of Report2013-08-27
Date of Event2013-08-06
Report Date2013-08-27
Date Reported to FDA2013-08-27
Date Reported to Mfgr2013-09-20
Date Added to Maude2013-09-20
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameXCEL
Generic NameTROCAR
Product CodeGCJ
Date Received2013-08-27
Model Number*
Catalog NumberB15LT
Lot NumberLOT # K4CZ72
ID Number*
OperatorPHYSICIAN
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerETHICON ENDO-SURGERY, INC.
Manufacturer Address4545 CREEK ROAD CINCINNATI OH 45242 US 45242

Device Sequence Number: 2

Brand Name*
Generic NameTROCAR
Product CodeNMK
Date Received2013-08-27
Model Number*
Catalog NumberCB5LT
Lot Number2503719
ID Number*
Device AvailabilityY
Device Sequence No2
Device Event Key0
ManufacturerETHICON ENDO SURGERY, INC.
Manufacturer Address4545 CREEK ROAD CINCINNATI OH 45242 US 45242

Patients

Patient NumberTreatmentOutcomeDate
10 2013-08-27
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