MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2002-06-12 for HGM K10-A-K08-1-73 ZEISS THIN SHUTTER K8 manufactured by Fisma.
[18480797]
Doctor started the procedure and the first time he fired the laser he reported seeing a green flash of light. For the rest of the procedure he wore safety filter glasses and completed the procedure. There was no injury to the patient. Later the doctor was checked by the ophthalmology department of the clinic and no injury was found. Bio-tech reported that there were no error codes indicating a fault condition in the laser system during the procedure. Later in the day the shutter was caused to malfunction by clinic staff and an error code did prevent the laser from firing. The device then was packaged and returned to manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1720381-2002-00004 |
| MDR Report Key | 400077 |
| Report Source | 06 |
| Date Received | 2002-06-12 |
| Date of Report | 2002-05-20 |
| Date of Event | 2002-05-20 |
| Date Mfgr Received | 2002-05-20 |
| Device Manufacturer Date | 2001-10-01 |
| Date Added to Maude | 2002-06-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Manufacturer Contact | DOUGLAS KANE |
| Manufacturer Street | 3959 WEST 1820 SOUTH |
| Manufacturer City | SALT LAKE CITY UT 84104 |
| Manufacturer Country | US |
| Manufacturer Postal | 84104 |
| Manufacturer Phone | 8016562610 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HGM |
| Generic Name | MICROSCOPE LASER FILTER |
| Product Code | LQJ |
| Date Received | 2002-06-12 |
| Returned To Mfg | 2002-05-24 |
| Model Number | K10-A-K08-1-73 |
| Catalog Number | ZEISS THIN SHUTTER K8 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 389128 |
| Manufacturer | FISMA |
| Manufacturer Address | 3959 WEST 1820 SOUTH SALT LAKE CITY UT 84104 US |
| Baseline Brand Name | HGM |
| Baseline Generic Name | MICROSCOPE LASER FILTER |
| Baseline Model No | K10-A-K08-1-73 |
| Baseline Catalog No | ZEISS THIN SHUTTER K8 |
| Baseline ID | ZEISS THIN SHUT |
| Baseline Device Family | S100 SERIES SINGLE THIN MICROSURGERY FILTER |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K904342 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-06-12 |