MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-27 for GREENLIGHT MOXY FIBER OPTIC 0010-2400 manufactured by Boston Scientific Corporation.
[185813249]
It was reported that after approximately 153,000 joules and 22 minutes at 120w, the fiber stopped firing at 90 degrees and began emitting energy straight out the end of the fiber during a photoselective vaporization of the prostate (pvp) procedure. The procedure was completed utilizing another of the same device. There were no clinical consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937094-2020-00355 |
| MDR Report Key | 9891941 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-23 |
| Date Mfgr Received | 2020-03-19 |
| Device Manufacturer Date | 2019-08-29 |
| Date Added to Maude | 2020-03-27 |
| 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 | 2020-03-27 |
| Model Number | 0010-2400 |
| Catalog Number | 0010-2400 |
| Lot Number | 0024344980 |
| 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 | 2020-03-27 |