MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2000-06-30 for HGM K45-A-K03-1-02 S40 (SMARTSCAN) MONOSHUTTER manufactured by Fisma.
[16037348]
Hgm svc engineer was installing a new monoshutter with k3 laser and observed that the laser fired without closing the shutter on the monoshutter. No pts or hosp presonnel were involved, because the problem was found during installion. The svc engineer removed monoshutter from the system, packaged unit and returned it to the factory for further investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1720381-2000-00003 |
| MDR Report Key | 284769 |
| Report Source | 00,07 |
| Date Received | 2000-06-30 |
| Date of Report | 2000-06-30 |
| Date of Event | 2000-06-01 |
| Date Mfgr Received | 2000-06-01 |
| Device Manufacturer Date | 1999-07-01 |
| Date Added to Maude | 2000-07-10 |
| 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 |
| Reporter Occupation | SERVICE PERSONNEL |
| 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 | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HGM |
| Generic Name | MONOSHUTTER |
| Product Code | IQJ |
| Date Received | 2000-06-30 |
| Returned To Mfg | 2000-06-28 |
| Model Number | K45-A-K03-1-02 |
| Catalog Number | S40 (SMARTSCAN) MONOSHUTTER |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 275577 |
| Manufacturer | FISMA |
| Manufacturer Address | 3959 WEST 1820 SOUTH SALT LAKE CITY UT 84104 US |
| Baseline Brand Name | HGM |
| Baseline Generic Name | MONOSHUTTER |
| Baseline Model No | K45-A-K03-1-02 |
| Baseline Catalog No | S40 (SMART SCAN) MONOSHUTTER |
| Baseline ID | ENDO FILTER |
| Baseline Device Family | S40 SERIES |
| 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 | 2000-06-30 |