HARMONIC ACE PLUS 7 ADV HEMOSTASIS 23 Adverse Event — Malfunction (MDR 3005075853-2020-02399)
HARMONIC ACE PLUS 7 ADV HEMOSTASIS 23 Adverse Event — Malfunction (MDR 3005075853-2020-02399) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HARMONIC ACE PLUS 7 ADV HEMOSTASIS 23; Generic name: INSTRUMENT, ULTRASONIC SURGICAL; Manufacturer: ETHICON ENDO-SURGERY, LLC..
| Device | HARMONIC ACE PLUS 7 ADV HEMOSTASIS 23 |
|---|---|
| Generic name | INSTRUMENT, ULTRASONIC SURGICAL |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Report number | 3005075853-2020-02399 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | (B)(4). BATCH # T9462L. INVESTIGATION SUMMARY THE ANALYSIS RESULTS FOUND THAT THE HARH23 DEVICE WAS RETURNED WITH NO APPARENT DAMAGE. IN ADDITION, THE TYVEK WAS RETURNED ALONG WITH THE INSTRUMENT. UPON VISUAL INSPECTION OF THE TYVEK, IT WAS OBSERVED THAT A PIECE OF BLISTER WAS BROKEN AND STILL ADHERED TO IT. DUE TO THE DAMAGES FOUND ON THE BLISTER, A POSSIBLE CAUSE FOR THIS CONDITION IS DUE TO IMP |
| Source | openFDA MAUDE (device adverse events) |
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