PROXIMATE*PPH PROCEDURE SET Adverse Event — Malfunction (MDR 3005075853-2020-02314)
PROXIMATE*PPH PROCEDURE SET Adverse Event — Malfunction (MDR 3005075853-2020-02314) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PROXIMATE*PPH PROCEDURE SET; Generic name: STAPLE, IMPLANTABLE; Manufacturer: ETHICON ENDO-SURGERY, LLC..
| Device | PROXIMATE*PPH PROCEDURE SET |
|---|---|
| Generic name | STAPLE, IMPLANTABLE |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Report number | 3005075853-2020-02314 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | (B)(4). DATE SENT: 05/26/2020. D4: BATCH # T5DD6A. DEVICE ANALYSIS: THE ANALYSIS RESULTS FOUND THAT THE PPH03 DEVICE ARRIVED WITH NO APPARENT DAMAGE. THE BREAKAWAY WASHER WAS PRESENT, CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY. IT FIR |
| Source | openFDA MAUDE (device adverse events) |
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