PENTAX Adverse Event — Malfunction (MDR 9610877-2020-00076)
PENTAX Adverse Event — Malfunction (MDR 9610877-2020-00076) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PENTAX; Generic name: VIDEO DUODENOSCOPE; Manufacturer: HOYA CORPORATION PENTAX TOKYO OFFICE.
| Device | PENTAX |
|---|---|
| Generic name | VIDEO DUODENOSCOPE |
| Manufacturer | HOYA CORPORATION PENTAX TOKYO OFFICE |
| Report number | 9610877-2020-00076 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE |
| Narrative | BASED ON DISCUSSION WITH FDA ON MAY 8, 2017, ALL INSPECTIONAL FAILURES ARE BEING REPORTED AS MDRS NOTWITHSTANDING THE FACT THAT THE PRESENCE OF DISCONTINUITIES, GAPS OR BUBBLES DOES NOT NECESSARILY HAVE EITHER TECHNICAL OR CLINICAL SIGNIFICANCE. (B)(4). |
| Source | openFDA MAUDE (device adverse events) |
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