ULTRACISION SURG DEV, CURVED SHEARS, ENDO LCSXX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-09-20 for ULTRACISION SURG DEV, CURVED SHEARS, ENDO LCSXX manufactured by Ethicon Endo-surgery, Inc..

Event Text Entries

[17685655] Info anticipated, but unavailable at this time.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1527736-2006-04902
• MDR Report Key: 763968
• Report Source: 07
• Date Received: 2006-09-20
• Date of Report: 2006-08-29
• Date of Event: 2006-02-15
• Date Mfgr Received: 2006-08-29
• Date Added to Maude: 2006-09-26
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: GARY LEBLANC
• Manufacturer Street: 4545 CREEK RD
• Manufacturer City: CINCINNATI OH 452422803
• Manufacturer Country: US
• Manufacturer Postal: 452422803
• Manufacturer Phone: 5133378582
• Manufacturer G1: ETHICON ENDO SURGERY, INC (INDEPENDENCIA)
• Manufacturer Street: BLVD INDEPENDENCIA #1151
• Manufacturer City: JUAREZ CHIHUAHUA MEXICO
• Manufacturer Country: MX
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ULTRACISION SURG DEV, CURVED SHEARS, ENDO
• Generic Name: GEI
• Product Code: GRI
• Date Received: 2006-09-20
• Model Number: NA
• Catalog Number: LCSXX
• Lot Number: *
• ID Number: NA
• Device Availability: Y
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 751841
• Manufacturer: ETHICON ENDO-SURGERY, INC.
• Manufacturer Address: 4545 CREEK RD. CINCINNATI OH 452422839 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-09-20