HARMONIC LAP 5MM SHEAR 36CM Adverse Event — Malfunction (MDR 3005075853-2020-02392)
HARMONIC LAP 5MM SHEAR 36CM Adverse Event — Malfunction (MDR 3005075853-2020-02392) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HARMONIC LAP 5MM SHEAR 36CM; Generic name: INSTRUMENT, ULTRASONIC SURGICAL; Manufacturer: ETHICON ENDO-SURGERY, LLC..
| Device | HARMONIC LAP 5MM SHEAR 36CM |
|---|---|
| Generic name | INSTRUMENT, ULTRASONIC SURGICAL |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Report number | 3005075853-2020-02392 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | (B)(4). DATE SENT: 5/20/2020. INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND NOT RETURNED. THE REMAINING BLADE PORTION WAS SCRATCHED WITH EVIDENCE OF CONTACT WITH METAL IN OR OUT OF THE OPERATIVE FIELD. DURING FUNCTIONAL TESTING ON GEN11, AN ALERT SCREEN WAS DISPLAYED. A PROBABLE CAUSE FOR THE DEVICE TO STOP ACTIVATING AND THE GEN11 TO DISPLAY AN ALE |
| Source | openFDA MAUDE (device adverse events) |
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