LIGHTTRAIL SINGLE USE Adverse Event — Malfunction (MDR 3005099803-2020-01798)
LIGHTTRAIL SINGLE USE Adverse Event — Malfunction (MDR 3005099803-2020-01798) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: LIGHTTRAIL SINGLE USE; Generic name: POWERED LASER SURGICAL INSTRUMENT; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | LIGHTTRAIL SINGLE USE |
|---|---|
| Generic name | POWERED LASER SURGICAL INSTRUMENT |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 3005099803-2020-01798 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 10, 2020 THAT A LIGHTTRAIL SINGLE USE 270UM LASER FIBER WAS OPENED FOR USE IN A LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PREPARATION, BEFORE USING THE FIBER, A HOLE WAS NOTED ON THE POUCH. REPORTEDLY, THE TIP OF THE LASER FIBER PERFORATED THE PACKAGE AND DETACHED FROM THE FIBER BODY. THE PROCE |
| Source | openFDA MAUDE (device adverse events) |
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