MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-07-02 for VASCULAR PROBE 7151015ES manufactured by Synovis Surgical Innovations.
[113013423]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[113013424]
It was reported that particulate matter (pm) was observed within the inner pouch of a vascular probe. The pm was observed during incoming inspection and before patient use. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[120736709]
The device was received for evaluation. Visual inspection revealed particulate matter on the inside wall of the inner pouch. Microscopic inspection revealed that the particulate matter was a fiber. The reported particulate matter condition was verified; however, the size of the particulate matter was found to be within specification for this product. The sample met specification. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[120736710]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2018-04002 |
| MDR Report Key | 7655216 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-07-02 |
| Date of Report | 2018-08-02 |
| Date of Event | 2018-03-06 |
| Date Mfgr Received | 2018-07-26 |
| Device Manufacturer Date | 2018-02-06 |
| Date Added to Maude | 2018-07-02 |
| 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 Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | SYNOVIS SURGICAL INNOVATIONS |
| Manufacturer Street | 2575 UNIVERSITY AVE W |
| Manufacturer City | SAINT PAUL MN 55114 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55114 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VASCULAR PROBE |
| Generic Name | DILATOR, VESSEL, SURGICAL |
| Product Code | DWP |
| Date Received | 2018-07-02 |
| Returned To Mfg | 2018-06-21 |
| Model Number | NA |
| Catalog Number | 7151015ES |
| Lot Number | SP18B051270625 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNOVIS SURGICAL INNOVATIONS |
| Manufacturer Address | SAINT PAUL MN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-02 |