LAPRA-TY ABSORBABLE X6::SUTURE CLIP Adverse Event — Malfunction (MDR 2210968-2020-03553)
LAPRA-TY ABSORBABLE X6::SUTURE CLIP Adverse Event — Malfunction (MDR 2210968-2020-03553) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: LAPRA-TY ABSORBABLE X6::SUTURE CLIP; Generic name: CLIP, IMPLANTABLE; Manufacturer: ETHICON INC..
| Device | LAPRA-TY ABSORBABLE X6::SUTURE CLIP |
|---|---|
| Generic name | CLIP, IMPLANTABLE |
| Manufacturer | ETHICON INC. |
| Report number | 2210968-2020-03553 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | (B)(4). DATE SENT TO THE FDA: 6/19/2020. ADDITIONAL H3 INVESTIGATION SUMMARY: IT WAS REPORTED THAT: CLIP HOLD ERROR. THE ANALYSIS RESULTS OF THE XC200 RELOAD WAS RECEIVED WITH NO APPARENT DAMAGED WITH 4 CLIPS WERE RECEIVED LOOSE AND ONE THEM WAS RECEIVED CLOSED. THE CLIPS WERE VISUALLY INSPECTION AND NO DEFECTS WERE OBSERVED. THE CLIPS WERE MANUALLY LOADED ON A TEST DEVICE FOR ITS FUNCTIONALITY. U |
| Source | openFDA MAUDE (device adverse events) |
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