LIGAMAX-5MM ENDO CLIP APPLIER Adverse Event — Malfunction (MDR 3005075853-2020-02391)
LIGAMAX-5MM ENDO CLIP APPLIER Adverse Event — Malfunction (MDR 3005075853-2020-02391) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: LIGAMAX-5MM ENDO CLIP APPLIER; Generic name: CLIP, IMPLANTABLE; Manufacturer: ETHICON ENDO-SURGERY, LLC..
| Device | LIGAMAX-5MM ENDO CLIP APPLIER |
|---|---|
| Generic name | CLIP, IMPLANTABLE |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Report number | 3005075853-2020-02391 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | (B)(4). BATCH # U93204. INVESTIGATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RECEIVED WITH NO DAMAGE IN THE EXTERNAL COMPONENTS. UPON CYCLING, THE INSTRUMENT WAS NOTED TO BE EMPTY AND LOCKED OUT. AS THE DEVICE WAS RETURNED EMPTY, NO TEST FIRING OF THE CLIPS COULD BE PERFORMED TO DETERMINE IF ANY THERE WERE ANY CLIP MALFORMATION ISSUES. THE INSTRUMENT IS DESIGNED TO LOCK OUT |
| Source | openFDA MAUDE (device adverse events) |
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