VIRTUOSAPH PLUS, WITH RADIAL Adverse Event — Injury (MDR 1124841-2020-00099)
VIRTUOSAPH PLUS, WITH RADIAL Adverse Event — Injury (MDR 1124841-2020-00099) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: VIRTUOSAPH PLUS, WITH RADIAL; Generic name: LAPAROSCOPE, GENERAL; Manufacturer: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION.
| Device | VIRTUOSAPH PLUS, WITH RADIAL |
|---|---|
| Generic name | LAPAROSCOPE, GENERAL |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
| Report number | 1124841-2020-00099 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, DISTRI |
| Narrative | THE AFFECTED SAMPLE WAS INSPECTED UPON RECEIPT. THE BIPOLAR CORD WAS CUT TO JUST BE A PIGTAIL. ELECTRICAL TESTING CONFIRMED POOR CONTINUITY IN THE DEVICE. THE INSPECTION SHOWED BURN MARKS ON THE V-CUTTER. A REPRESENTATIVE RETENTION SAMPLE WAS REVIEWED AND ELECTRICALLY TESTED WITH NO ANOMALIES AND ALL ELECTRICAL TESTS WITHIN SPECIFICATION. THE V-CUTTER ON THE RETENTION SAMPLE WAS FULLY INTACT. (B)( |
| Source | openFDA MAUDE (device adverse events) |
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