MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-25 for GREENLIGHT MOXY FIBER OPTIC 0010-2400 manufactured by Boston Scientific Corporation.
[184910341]
It was reported that the fiber tip ruptured/broke at 27,604 j with 3:05 minutes of use. The fiber was cleaned during the procedure. The fiber was replaced and the procedure completed using a second fiber. Patient outcome was not reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937094-2020-00336 |
| MDR Report Key | 9879278 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2019-11-19 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-06-21 |
| 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 | PMT 741 PERSIARAN CASSIA SELAT |
| Manufacturer City | BANDARCASSIA, PULAU PINAN 14110 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 14110 |
| 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 | 0023988327 |
| 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 | PMT 741 PERSIARAN CASSIA SELAT BANDARCASSIA, PULAU PINAN 14110 MY 14110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |