MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-12 for LEXER GOUGE PEEK-HDL 10MM225MM FL413R manufactured by Aesculap Ag.
[46321373]
(b)(4). Manufacturing site evaluation: evaluation on-going. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[46321374]
Country of complaint: (b)(6). Piece broke off the metal. The customer does not know if it was during use in the o. R. Or if it was during washing. The incident has been reported to the (b)(6) health auth, and the customer is considering if they should take x-ray of the patient from the day this incident occured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2016-00362 |
| MDR Report Key | 5650233 |
| Date Received | 2016-05-12 |
| Date of Report | 2018-02-23 |
| Date Facility Aware | 2016-05-03 |
| Date Mfgr Received | 2016-02-16 |
| Date Added to Maude | 2016-05-12 |
| 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 | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LEXER GOUGE PEEK-HDL 10MM225MM |
| Generic Name | GENERAL SURGICAL INSTRUMENTS |
| Product Code | GDH |
| Date Received | 2016-05-12 |
| Model Number | FL413R |
| Catalog Number | FL413R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-12 |