MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2000-11-17 for HGM K10-A-K03-1-73 ZEISS THIN SHUTTER K3 manufactured by Fisma.
[139724]
The shutter intermittently did not close completely thus exposing the doctor and assistant. The doctor reported that this malfunction had happened several times over the past few months. There were no reported injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1720381-2000-00005 |
| MDR Report Key | 306221 |
| Report Source | 00,05,06 |
| Date Received | 2000-11-17 |
| Date of Report | 2000-11-15 |
| Date of Event | 2000-01-01 |
| Date Mfgr Received | 2000-10-24 |
| Device Manufacturer Date | 1999-09-01 |
| Date Added to Maude | 2000-11-30 |
| 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 | 8019720500 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HGM |
| Generic Name | SHUTTER |
| Product Code | LQJ |
| Date Received | 2000-11-17 |
| Model Number | K10-A-K03-1-73 |
| Catalog Number | ZEISS THIN SHUTTER K3 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 296368 |
| Manufacturer | FISMA |
| 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 | 2000-11-17 |