EPIC I *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-08-30 for EPIC I * manufactured by Coherent, Inc..

Event Text Entries

[14870017] Pt's eyes were dilated in prepraration for yag laser treatment. Machine had been turned on but failed to operate for md when 1st of three pts taken into room for procedure.
Patient Sequence No: 1, Text Type: D, B5

[15137197] Pt's eyes were dilated in proportion for yag laser treatment. Machine had been turned on but failed to operate for md when 1st of three pts taken into room for procedure.
Patient Sequence No: 2, Text Type: D, B5

[15225055] Pt's eyes were dilated in proportion for yag laser treatment. Machine had been turned on but failed to operate for md when 1st of three pts taken into room for procedure.
Patient Sequence No: 3, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1017105
• MDR Report Key: 238808
• Date Received: 1999-08-30
• Date of Report: 1999-08-27
• Date of Event: 1999-08-24
• Date Added to Maude: 1999-09-09
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EPIC I
• Generic Name: YAG LASER
• Product Code: LOI
• Date Received: 1999-08-30
• Model Number: EPIC I
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 231407
• Manufacturer: COHERENT, INC.
• Manufacturer Address: 2400 CONDENSA ST. SANTA CLARA CA 950510901 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-08-30
2	0	1. Other	1999-08-30
3	0	1. Other	1999-08-30