END 08 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-15 for END 08 N/A manufactured by Hgm Argon Laser.

Event Text Entries

[15710834] Hgm argon laser was being used with zeiss microscpoe for eye surgery when ophthalmology resident using observer binoculars received direct laser reflection to his eyes. The assembly had been put together incorrectly by hospital staff or service representative with the lase filter shutter misplaced as follows: 1 patient - 2 main body - 3 accessory unit (containing observers binoculars) - 4 laser shutter/filter - 5 operator binocular instead of as intended 1-2-4-3-5-. Items 2, 3 & 5 are manufactured by zeiss and item 4 is manufacyured by hgm. Resident suffered only temporary visual impairmentdevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-apr-92. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Device not used as labeled/indended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, other, other, invalid data. Results of evaluation: design - inadequate, failure to follow instructions. Conclusion: user error contributed to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device repaired and put back in service, user education provided, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 896
• MDR Report Key: 896
• Date Received: 1992-07-15
• Date of Report: 1992-07-08
• Date of Event: 1992-06-25
• Date Facility Aware: 1992-06-25
• Report Date: 1992-07-08
• Date Reported to FDA: 1992-07-08
• Date Reported to Mfgr: 1992-07-01
• Date Added to Maude: 1992-07-21
• 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: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Product Code: LMS
• Date Received: 1992-07-15
• Model Number: END 08
• Catalog Number: N/A
• Lot Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-AUG-83
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 853
• Manufacturer: HGM ARGON LASER

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-15