MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-11 for VARADY MINI-VARIX EXDISSECTOR 170MM FB126R manufactured by Aesculap Ag.
[31220644]
Manufacturing site evaluation: on-going.
Patient Sequence No: 1, Text Type: N, H10
[31220645]
Hook end of the device is missing. Discovered during procedure on (b)(6) 2015; however, it is unknown when the device broke. It could have been broken when the device was put into the set, during processing or during the procedure. Surgeon did not notice an intra-operative break had occurred; however, did notice the piece of the device missing. X-ray was done in the recovery room; negative for a retained piece. Surgery was delayed for about five minutes to get another set. No patient injury.
Patient Sequence No: 1, Text Type: D, B5
[36610641]
(b)(4). Manufacturing site evaluation: one tip of the received instrument is broken off. The fracture surface indicates a spontaneous forced fracture occurred. Hardness testing indicated that the device material hardness is within specification. No material or manufacturing deviations were found; failure is user related. Corrective/preventive action is not required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2015-01036 |
| MDR Report Key | 5218976 |
| Date Received | 2015-11-11 |
| Date of Report | 2016-01-21 |
| Date of Event | 2015-09-24 |
| Date Facility Aware | 2015-09-25 |
| Date Mfgr Received | 2015-09-25 |
| Date Added to Maude | 2015-11-11 |
| 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 | 3 |
| Brand Name | VARADY MINI-VARIX EXDISSECTOR 170MM |
| Generic Name | VEIN STRIPPER |
| Product Code | GDI |
| Date Received | 2015-11-11 |
| Model Number | FB126R |
| Catalog Number | FB126R |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-11-11 |