MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-25 for GREENLIGHT MOXY FIBER OPTIC 0010-2400 manufactured by Boston Scientific Corporation.
[185249958]
It was reported that after 20 minutes of use the fiber began to forward fire. The bladder and prostate were checked and no injury was noted. There were no anomalies noted to the fiber prior to use. A second fiber was selected but it could not connect to the laser console. The procedure was completed using bi-polar turp without incident as no other fibers were available. There were no injuries to the surgeon or staff. This report is for the first fiber.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937094-2020-00345 |
| MDR Report Key | 9881261 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-02-14 |
| Date Added to Maude | 2020-03-25 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ALYSON HARRIS |
| Manufacturer Street | 150 BAYTECH DRIVE |
| Manufacturer City | SAN JOSE CA 95134 |
| Manufacturer Country | US |
| Manufacturer Postal | 95134 |
| Manufacturer Phone | 4089353452 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 150 BAYTECH DR. |
| Manufacturer City | SAN JOSE CA 95134 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95134 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GREENLIGHT MOXY FIBER OPTIC |
| Generic Name | POWERED LASER SURGICAL INSTRUMENT |
| Product Code | GEX |
| Date Received | 2020-03-25 |
| Model Number | 0010-2400 |
| Catalog Number | 0010-2400 |
| Lot Number | 0023348091 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 150 BAYTECH DRIVE SAN JOSE CA 95134 US 95134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |