BREVERA BIOPSY SYSTEM WITH CORLUMINA IMAGING TECHNOLOGY Adverse Event — Malfunction (MDR 1222780-2020-00076)
BREVERA BIOPSY SYSTEM WITH CORLUMINA IMAGING TECHNOLOGY Adverse Event — Malfunction (MDR 1222780-2020-00076) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: BREVERA BIOPSY SYSTEM WITH CORLUMINA IMAGING TECHNOLOGY; Generic name: BIOPSY INSTRUMENT; Manufacturer: HOLOGIC, INC..
| Device | BREVERA BIOPSY SYSTEM WITH CORLUMINA IMAGING TECHNOLOGY |
|---|---|
| Generic name | BIOPSY INSTRUMENT |
| Manufacturer | HOLOGIC, INC. |
| Report number | 1222780-2020-00076 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | FOREIGN, HEALTH PROFESSIONAL, U |
| Narrative | THE DEVICE HAS NOT YET BEEN RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF THE DEVICE IS RETURNED AND EVALUATION COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED IDENTIFICATION NUMBER. THE LOT WAS RELEASED MEETING ALL QA SPECIFICATIONS. |
| Source | openFDA MAUDE (device adverse events) |
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