ENSEAL G2 ART STRA SEALER 35CM Adverse Event — Malfunction (MDR 3005075853-2020-02375)
ENSEAL G2 ART STRA SEALER 35CM Adverse Event — Malfunction (MDR 3005075853-2020-02375) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ENSEAL G2 ART STRA SEALER 35CM; Generic name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES; Manufacturer: ETHICON ENDO-SURGERY, LLC..
| Device | ENSEAL G2 ART STRA SEALER 35CM |
|---|---|
| Generic name | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Report number | 3005075853-2020-02375 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE |
| Narrative | (B)(4). DATE SENT: 4/28/2020. BATCH # N92331. DEVICE ANALYSIS: THE DEVICE WAS RECEIVED WITH SKIVING OF THE HEAT SHRINK (SHAFT COVER) MATERIAL NOT ALL PRESENT. IN ADDITION, THE DEVICE WAS RECEIVED WITH THE UPPER JAW BENT AT THE PROXIMAL SIDE. THE DEVICE WAS CONNECTED TO THE GENERATOR AND IT WAS RECOGNIZED. BECAUSE OF THE CONDITION OF THE DEVICE, NOT ALL FUNCTIONAL TESTING COULD BE PERFORMED WITH TH |
| Source | openFDA MAUDE (device adverse events) |
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