MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-02 for VARADY VARIX EXTRACTOR W/CATCH 180MM FB122R manufactured by Aesculap Ag.
[122447812]
(b)(4). Investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[122447813]
It was reported that the top of an extractor broke off during a vericose vein procedure. The surgeon reported that a small metal fragment (1-2 mm) broke off from the tip of the device. The metal fragment that broke off of the instrument was not able to be retrieved from the patient's body. Attending nurse indicated that the surgeon does not feel that the patient has been seriously harmed or is at risk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00459 |
| MDR Report Key | 7928165 |
| Date Received | 2018-10-02 |
| Date of Report | 2018-10-30 |
| Date Facility Aware | 2017-09-28 |
| Date Mfgr Received | 2018-10-02 |
| Device Manufacturer Date | 2014-11-26 |
| Date Added to Maude | 2018-10-02 |
| 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 | VARADY VARIX EXTRACTOR W/CATCH 180MM |
| Generic Name | VEIN EXTRACTOR |
| Product Code | DWS |
| Date Received | 2018-10-02 |
| Returned To Mfg | 2018-09-24 |
| Model Number | FB122R |
| Catalog Number | FB122R |
| Lot Number | 4506198946 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-02 |