FLEXIVA (TM) ID TRACTIP HIGH POWER SINGLE-USE LASER FIBER Adverse Event — Malfunction (MDR 3005099803-2020-01719)
FLEXIVA (TM) ID TRACTIP HIGH POWER SINGLE-USE LASER FIBER Adverse Event — Malfunction (MDR 3005099803-2020-01719) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: FLEXIVA (TM) ID TRACTIP HIGH POWER SINGLE-USE LASER FIBER; Generic name: POWERED LASER SURGICAL INSTRUMENT; Manufactu
| Device | FLEXIVA (TM) ID TRACTIP HIGH POWER SINGLE-USE LASER FIBER |
|---|---|
| Generic name | POWERED LASER SURGICAL INSTRUMENT |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 3005099803-2020-01719 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | (B)(4). INVESTIGATION RESULTS: THE RETURNED FLEXIVA ID TRACTIP 200 LASER FIBER WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT IT WAS RETURNED IN ONE PIECE. THE FIBER MEASURED APPROXIMATELY 314 CM FROM THE TOP OF THE CONNECTOR TO THE TIP. THE EXPOSED GLASS TIP MEASURED APPROXIMATELY 3.5 MM AND APPEARED UNUSED. EXAMINATION UNDER MAGNIFICATION CONFIRMED THAT THE TIP WAS UNUSED. VISUAL EXAMINATION R |
| Source | openFDA MAUDE (device adverse events) |
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