DUAL EFFECT BARE LASER FIBER 600 MICRON DUAL EFFECT FIBER AA2214000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-09-22 for DUAL EFFECT BARE LASER FIBER 600 MICRON DUAL EFFECT FIBER AA2214000 manufactured by Laser Industries, Ltd..

Event Text Entries

[18190644] The respiratory therapist reported that during a bronchoscopy procedure being performed on an outpatient basis (pt statistics unknown) with a surgical laser, a tip of a laser fiber allegedly broke. The healthcare professional who gave this report, indicated that it was received as hearsay info. The device was discarded by the user facility & the pt did not experience any adverse consequences as a result of the event.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	8010121-1995-00002
MDR Report Key	26886
Date Received	1995-09-22
Date of Report	1995-09-22
Date of Event	1995-08-01
Date Facility Aware	1995-08-25
Report Date	1995-09-22
Date Reported to FDA	1995-09-22
Date Reported to Mfgr	1995-08-25
Date Added to Maude	1995-10-12
Event Key	0
Report Source Code	Distributor 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	RESPIRATORY THERAPIST
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	DUAL EFFECT BARE LASER FIBER
Generic Name	LASER FIBER
Product Code	LLO
Date Received	1995-09-22
Model Number	600 MICRON DUAL EFFECT FIBER
Catalog Number	AA2214000
Lot Number	25389
Operator	HEALTH PROFESSIONAL
Device Availability	N
Device Age	*
Implant Flag	N
Date Removed	B
Device Sequence No	1
Device Event Key	27668
Manufacturer	LASER INDUSTRIES, LTD.
Manufacturer Address	ATIDIM SCIENCE INDUSTRIAL PARK TEL AVIV IS 61131

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1995-09-22