MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-31 for AUTO ENDO5 ML AE05ML manufactured by Teleflex Medical.
[185916211]
(b)(4). The device history review could not be conducted since the lot number was not provided. The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[185916212]
It was reported that clips were not loaded into the jaws properly during use. No clips fell/remained in the patient and no health injury occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2020-00341 |
| MDR Report Key | 9902883 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-11 |
| Date of Event | 2019-04-08 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2018-11-19 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | EFFIE JEFFERSON |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194332672 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | RANCHO EL DESCANSO |
| Manufacturer City | TECATE 21478 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTO ENDO5 ML |
| Generic Name | CLIP, IMPLANTABLE |
| Product Code | FZP |
| Date Received | 2020-03-31 |
| Catalog Number | AE05ML |
| Lot Number | 73L1800541 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | MORRISVILLE NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |