VAPR3 GENERATOR *EA Adverse Event — Malfunction (MDR 1221934-2020-01252)
VAPR3 GENERATOR *EA Adverse Event — Malfunction (MDR 1221934-2020-01252) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: VAPR3 GENERATOR *EA; Generic name: ELECTROSURGICAL SYSTEM GENERATOR; Manufacturer: DEPUY MITEK LLC US.
| Device | VAPR3 GENERATOR *EA |
|---|---|
| Generic name | ELECTROSURGICAL SYSTEM GENERATOR |
| Manufacturer | DEPUY MITEK LLC US |
| Report number | 1221934-2020-01252 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | PRODUCT COMPLAINT #: (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AT THE SERVICE CENTER AND EVALUATED. IT WAS REPORTED THAT THE DEVICE COULD NOT COAGULATE. PER OPERATIONAL AND DIAGNOSTIC, THIS COMPLAINT CAN |
| Source | openFDA MAUDE (device adverse events) |
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