ENCOR BIOPSY PROBE Adverse Event — Malfunction (MDR 2020394-2020-03256)
ENCOR BIOPSY PROBE Adverse Event — Malfunction (MDR 2020394-2020-03256) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ENCOR BIOPSY PROBE; Generic name: BIOPSY INSTRUMENT; Manufacturer: BARD PERIPHERAL VASCULAR, INC..
| Device | ENCOR BIOPSY PROBE |
|---|---|
| Generic name | BIOPSY INSTRUMENT |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Report number | 2020394-2020-03256 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | A CUSTOMER NOTIFICATION WAS ISSUED FOR THE ENCOR BREAST BIOPSY PROBE FOR SPECIFIC PRODUCT CODE/LOT NUMBER COMBINATIONS. THE AFFECTED PRODUCT CODE/LOT NUMBER COMBINATIONS MAY BE AT RISK OF EXPERIENCING A LEAK BETWEEN THE PROBE AND THE TISSUE COLLECTION CHAMBER, WHICH COULD RESULT IN MINIMAL SUCTION, LEAKAGE, MINIMAL OR NO TISSUE SAMPLE OBTAINED, OR AN EGRESS OF FLUIDS FROM THE DEVICE. A ROOT CAUSE |
| Source | openFDA MAUDE (device adverse events) |
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