MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-08 for 5 MM ENDO CLIP APPLIER 176630 manufactured by Covidien Llc.
[174666793]
A piece of endo clip applier broke off within abdominal cavity while in use. Surgeon was able to retrieve the small particle. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092138 |
| MDR Report Key | 9570497 |
| Date Received | 2020-01-08 |
| Date of Report | 2020-01-07 |
| Date of Event | 2020-01-06 |
| Date Added to Maude | 2020-01-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5 MM ENDO CLIP APPLIER |
| Generic Name | APPLIER, SURGICAL, CLIP |
| Product Code | GDO |
| Date Received | 2020-01-08 |
| Model Number | 176630 |
| Lot Number | J7C0772X |
| Device Expiration Date | 2020-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-08 |