HARMONIC ACE PLUS 7 ADV HEMOSTASIS 45 Adverse Event — Malfunction (MDR 3005075853-2020-02394)
HARMONIC ACE PLUS 7 ADV HEMOSTASIS 45 Adverse Event — Malfunction (MDR 3005075853-2020-02394) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HARMONIC ACE PLUS 7 ADV HEMOSTASIS 45; Generic name: INSTRUMENT, ULTRASONIC SURGICAL; Manufacturer: ETHICON ENDO-SURGERY, LLC..
| Device | HARMONIC ACE PLUS 7 ADV HEMOSTASIS 45 |
|---|---|
| Generic name | INSTRUMENT, ULTRASONIC SURGICAL |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Report number | 3005075853-2020-02394 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | (B)(4). DATE SENT: 5/21/2020. INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED WITH THE TISSUE PAD DAMAGED, MELTED AND 100% PRESENT. IN ADDITION, THE TISSUE PAD WAS ATTACHED TO THE CLAMP ARM AND NOT DETACHED AS REPORTED BY THE CUSTOMER. THE DEVICE WAS CONNECTED TO A TEST HAND PIECE AND A GEN11, AND THE DEVICE DID ACTIVATE DURING FUNCTIONAL TESTING. THE DEVICE WAS DISASSEMBLED TO INSPECT THE INTERNAL |
| Source | openFDA MAUDE (device adverse events) |
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