MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-03 for SOLTIVE SUPER PULSED LASER FIBER TFL-FBX3565S manufactured by Gyrus Acmi, Inc..
[177377461]
During use, fiber at attachment to machine started to smoke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9659259 |
| MDR Report Key | 9659259 |
| Date Received | 2020-02-03 |
| Date of Report | 2020-01-24 |
| Date of Event | 2020-01-21 |
| Report Date | 2020-01-24 |
| Date Reported to FDA | 2020-01-24 |
| Date Reported to Mfgr | 2020-02-03 |
| Date Added to Maude | 2020-02-03 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOLTIVE SUPER PULSED LASER FIBER |
| Generic Name | ENDOSCOPE, RIGID |
| Product Code | GCM |
| Date Received | 2020-02-03 |
| Model Number | TFL-FBX3565S |
| Lot Number | KR869075 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. |
| Manufacturer Address | 2925 APPLING RD BARTLETT TN 38133 US 38133 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-03 |