MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-24 for AUTO ENDO5 ML AE05ML manufactured by Teleflex Medical.
[184804943]
(b)(4). The device history review for the product auto endo5 ml lot #73g1900661 investigation did not show issues related to the complaint. The device investigation is pending. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[184804944]
The report states: we had an incident on 2/28 with a couple of endo clip appliers item number ae05ml they were both different lot numbers. Per the nurse when they deployed it, there was a delay and so they took it out of the patient's body and the metal tip/clip broke and stayed in the patient's body. We have both of these in a red bag i don't know if we can ship them off to be reviewed. The doctor also has pictures of what exactly happened if you would like those. The lot numbers are: 73g1900661 and 73g1900662.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2020-00285 |
| MDR Report Key | 9873338 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-07-23 |
| Date Added to Maude | 2020-03-24 |
| 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 | 2020-03-24 |
| Returned To Mfg | 2020-03-13 |
| Catalog Number | AE05ML |
| Lot Number | 73G1900661 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | MORRISVILLE NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |