LASER 8 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-06-13 for LASER 8 NA manufactured by Hgm, Inc..

Event Text Entries

[19959578] The laser was then used to apply photocoagulation to the periphery as well as to bleeders. At the start of the laser there was a first shot with setting on 0. 2 watts. There was an intense retinal break with a resultant retinal hole created. There were two other times when the laser appeared to have surges where two other small retinal breaks were created. Laser had malfunctioned causing multiple retinal holes. The evening prior to the surgery, the svc rep did preventive maintenance on the machine. The machine was not used after this servicing until this surgery was done.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 14560
• MDR Report Key: 14560
• Date Received: 1994-06-13
• Date of Report: 1994-06-13
• Date of Event: 1994-06-09
• Date Facility Aware: 1994-06-09
• Report Date: 1994-06-13
• Date Reported to Mfgr: 1994-06-14
• Date Added to Maude: 1994-07-08
• 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
• 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: LASER
• Generic Name: LASER
• Product Code: HQB
• Date Received: 1994-06-13
• Model Number: 8
• Catalog Number: NA
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 8 YR
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 14554
• Manufacturer: HGM, INC.
• Manufacturer Address: SALT LAKE CITY UT 84104 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1994-06-13