GAS FIBER ASEMBLY 1.8 MILIMETER *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-01-02 for GAS FIBER ASEMBLY 1.8 MILIMETER * manufactured by Ceramoptic.

Event Text Entries

[75336] Air embolus during yag laser bronchoscopy. This was not a device malfunction. This report described an air embolus which occurred during a yag laser bronchoscopy and which resulted in a pt death. Air embolism is a known complication of this procedure. The etiology of air embolism was not understood until some recent research which was conducted by a group from yale. The results of this research are so new that they are not yet published. A paper is expected to be published on this topic soon. The research suggests that a change in technique in the use of the yag laser in this procedure will reduce the likelihood of experiencing this complication.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 141329
• MDR Report Key: 141329
• Date Received: 1998-01-02
• Date of Report: 1997-12-30
• Date of Event: 1997-09-26
• Date Facility Aware: 1997-09-26
• Report Date: 1997-12-30
• Date Reported to FDA: 1997-12-30
• Date Reported to Mfgr: 1997-12-30
• Date Added to Maude: 1998-01-06
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• 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: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: GAS FIBER ASEMBLY 1.8 MILIMETER
• Generic Name: GAS COOLED LASER FIBER
• Product Code: EWG
• Date Received: 1998-01-02
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: PART #GLC-0180
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 137921
• Manufacturer: CERAMOPTIC
• Manufacturer Address: 515 SHAKER RD EAST LONGMEADOW MA 01028 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1998-01-02