MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-12-07 for VASCULAR PROBES 7081015ES manufactured by Synovis Surgical Innovations.
[94224809]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[94224810]
It was reported that there was particulate matter in the inner pouch of three (3) vascular probes. This was noticed before use. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[104196498]
Additional information added to three (3) devices were returned for evaluation. A visual inspection was performed on the three samples. Loose particulate matter (pm) was present on the outside wall of the inner pouch of one unit and inside wall of the inner pouch for the other two units. The pm was inspected under the microscope and it was determined that the particle size was under 0. 80 mm squared for two of the devices and over 0. 80 mm squared for the third device. The particle size over 0. 80 mm squared in the one sample did not meet specification. The reported condition was verified in one sample. The cause of the reported condition was a manufacturing 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
| Report Number | 1416980-2017-09614 |
| MDR Report Key | 7095182 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-12-07 |
| Date of Report | 2018-01-11 |
| Date of Event | 2017-06-22 |
| Date Mfgr Received | 2018-01-05 |
| Date Added to Maude | 2017-12-07 |
| 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 PROBES |
| Generic Name | DILATOR, VESSEL, SURGICAL |
| Product Code | DWP |
| Date Received | 2017-12-07 |
| Returned To Mfg | 2017-12-01 |
| Model Number | NA |
| Catalog Number | 7081015ES |
| Lot Number | SP17D261228263 |
| ID Number | NA |
| 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 | 2017-12-07 |