MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 1999-03-26 for HGM K10-A-K03-1-73 ZEISS THIN SHUTTER,K3, (MORE) manufactured by Fisma, Inc..
[15037230]
Physician was performing procedure using a zeiss thin shutter microfilter with an argon laser. Physician noticed a minimal amount of green light flashback. Physician put on goggles and completed the procedure. User facility reported that there was no significant exposure and no follow-up done on their part. There was no injury to physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1720381-1999-00004 |
| MDR Report Key | 216744 |
| Report Source | 05,06,07 |
| Date Received | 1999-03-26 |
| Date of Report | 1999-02-17 |
| Date of Event | 1999-02-17 |
| Date Mfgr Received | 1999-02-17 |
| Device Manufacturer Date | 1997-04-01 |
| Date Added to Maude | 1999-04-01 |
| 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 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HGM |
| Generic Name | ARGON MICROFILTER |
| Product Code | LQJ |
| Date Received | 1999-03-26 |
| Returned To Mfg | 1999-03-17 |
| Model Number | K10-A-K03-1-73 |
| Catalog Number | ZEISS THIN SHUTTER,K3, (MORE) |
| 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 | 210248 |
| Manufacturer | FISMA, INC. |
| Manufacturer Address | 3959 WEST 1820 SOUTH SALT LAKE CITY UT 84104 US |
| Baseline Brand Name | HGM |
| Baseline Generic Name | ARGON MICROFILTER |
| Baseline Model No | K10-A-K03-1-73 |
| Baseline Catalog No | ZEISS THIN SHUTTER K3 |
| 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 | 1. Other | 1999-03-26 |