BARD MAX-CORE DISPOSABLE CORE BIOPSY INSTRUMENT Adverse Event — Malfunction (MDR 2020394-2020-03289)
BARD MAX-CORE DISPOSABLE CORE BIOPSY INSTRUMENT Adverse Event — Malfunction (MDR 2020394-2020-03289) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: BARD MAX-CORE DISPOSABLE CORE BIOPSY INSTRUMENT; Generic name: BIOPSY INSTRUMENT; Manufacturer: BARD PERIPHERAL VASCULAR, INC..
| Device | BARD MAX-CORE DISPOSABLE CORE BIOPSY INSTRUMENT |
|---|---|
| Generic name | BIOPSY INSTRUMENT |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Report number | 2020394-2020-03289 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | A VOLUNTARY RECALL WAS ISSUED FOR THE MAX-CORE DISPOSABLE CORE BIOPSY INSTRUMENT FOR SPECIFIC PRODUCT CODE/LOT NUMBER COMBINATIONS. THE AFFECTED PRODUCT CODE/LOT NUMBER COMBINATIONS MAY BE AT RISK OF HAVING FIRING ISSUES. AN EXAMPLE OF A FIRING ISSUE IS WHERE THE DEVICE DOES NOT COMPLETELY FIRE, RESULTING IN THE INABILITY TO OBTAIN TISSUE SAMPLES. A ROOT CAUSE INVESTIGATION AND FIELD ACTION DETERM |
| Source | openFDA MAUDE (device adverse events) |
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