MEGABEAM GAS FIBER ASSEMBLY 1.8MM *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-01-08 for MEGABEAM GAS FIBER ASSEMBLY 1.8MM * manufactured by Ceramoptec, Inc..

Event Text Entries

[78149] The co received a med watch report from medical center indicating that a pt had died due to any air embolus during a bronchoscopy procedure using an nd:yag laser. The laser is not mfg by ceramoptec. Ceramoptec mfr the fiber optic delivery system that was used during the procedure. The hospitals report indicated that the air embolism is a known complication of this procedure. The hospital also stated that the device did not malfunction. Although cermoptec does not believe its fiber optic system caused or contributed to the pt death, the company is reporting this incident to fda in the spirit of the mdr regulation.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1222625-1998-00001
• MDR Report Key: 142524
• Report Source: 05
• Date Received: 1998-01-08
• Date of Report: 1998-01-08
• Date of Event: 1997-09-26
• Date Mfgr Received: 1998-01-05
• Date Added to Maude: 1998-01-13
• 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: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MEGABEAM GAS FIBER ASSEMBLY 1.8MM
• Generic Name: GAS COOLED FIBER OPTIC DELIVERY SYSTEM
• Product Code: EWG
• Date Received: 1998-01-08
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: PART NUMBER GLC-0180
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 139008
• Manufacturer: CERAMOPTEC, INC.
• Manufacturer Address: 515 SHAKER ROAD EAST LONGMEADOW MA 01028 US
• Baseline Brand Name: MEGABEAM GAS FIBER ASSEMBLY 1.8MM
• Baseline Generic Name: GAS COOLED FIBER OPTIC DELIVERY SYSTEM
• Baseline Model No: *
• Baseline Catalog No: *
• Baseline ID: PART NUMBER GLC

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1998-01-08