GREENLIGHT MOXY FIBER OPTIC Adverse Event — Malfunction (MDR 2937094-2020-00415)
GREENLIGHT MOXY FIBER OPTIC Adverse Event — Malfunction (MDR 2937094-2020-00415) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: GREENLIGHT MOXY FIBER OPTIC; Generic name: POWERED LASER SURGICAL INSTRUMENT; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | GREENLIGHT MOXY FIBER OPTIC |
|---|---|
| Generic name | POWERED LASER SURGICAL INSTRUMENT |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 2937094-2020-00415 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | DISTRIBUTOR |
| Narrative | IT WAS REPORTED THAT DURING A BENIGN PROSTATIC HYPERPLASIA PROCEDURE, AFTER 149,180 JOULES AND 31:27 MINUTES OF USE THE LASER BEGAN FLASHING. THE METAL CAP CAME LOOSE DURING THE CASE AND WHEN THE PHYSICIAN REMOVED THE FIBER, THE METAL END FELL OFF OUTSIDE THE PATIENT. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING HANDLING OR USE THAT COULD HAVE CONTRIBUTED TO THE EVENT AND NO COURTESY MESSAGE PROM |
| Source | openFDA MAUDE (device adverse events) |
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