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 2018-06-29 for VASCULAR PROBE 7151015 manufactured by Synovis Surgical Innovations.
[113012589]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[113012590]
It was reported that particulate matter (pm) was observed in the inner pouch of two (2) vascular probes. The pm was discovered during incoming inspection by the distributor. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[117885108]
Two devices were received for evaluation. A visual inspection was performed and particulate matter (pm) was observed on the inside wall of the inner pouch in sample #1 and on the probe tip in sample #2. Microscopic inspection of the pm was performed and it was determined to be fiber. The size of the pm was in sample #1 was small enough to meet specification. In sample #2, the pm was embedded on the coated probe tip which did not meet specification. The reported condition was verified. The cause of the reported condition was a manufacturing error. A nonconformance has been opened to address this issue. 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
[117885109]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2018-03982 |
| MDR Report Key | 7653427 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-06-29 |
| Date of Report | 2018-08-02 |
| Date of Event | 2018-03-05 |
| Date Mfgr Received | 2018-07-26 |
| Device Manufacturer Date | 2018-01-04 |
| Date Added to Maude | 2018-06-29 |
| 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 | 2018-06-29 |
| Returned To Mfg | 2018-06-21 |
| Model Number | NA |
| Catalog Number | 7151015 |
| Lot Number | SP18A041265559 |
| 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 | 2018-06-29 |