MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-07-25 for VASCULAR PROBE 745105 NA manufactured by Synovis Surgical Innovations.
[18995329]
The vascular probe was returned to synovis surgical innovations for evaluation. The failure mode of the device could not be duplcated during the evaluation. The device malfunction is inconclusive. If additional pertinent information becomes available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[19052048]
Patient had a lubal procedure requiring the creation of an anastomosis. The surgeon used a vascular probe to provide structure to the anastomosis. After creation of the anastomosis, the probe was removed and broke into 4 pieces when coming through the end of the tube. No patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183620-2006-00015 |
| MDR Report Key | 745675 |
| Report Source | 05 |
| Date Received | 2006-07-25 |
| Date of Report | 2006-07-25 |
| Date of Event | 2006-06-16 |
| Date Mfgr Received | 2006-06-26 |
| Date Added to Maude | 2006-08-10 |
| 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 | 0 |
| Manufacturer Contact | JANICE KELLER |
| Manufacturer Street | 2575 UNIVERSITY AVE W |
| Manufacturer City | ST PAUL MN 551141024 |
| Manufacturer Country | US |
| Manufacturer Postal | 551141024 |
| Manufacturer Phone | 6517967800 |
| Manufacturer G1 | SYNOVIS SURGICAL INNOVATIONS |
| Manufacturer Street | 2575 UNIVERSITY AVE W |
| Manufacturer City | ST PAUL MN 55114102 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55114 1024 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VASCULAR PROBE |
| Generic Name | VESSEL DILATOR |
| Product Code | FKA |
| Date Received | 2006-07-25 |
| Returned To Mfg | 2006-06-26 |
| Model Number | 745105 |
| Catalog Number | NA |
| Lot Number | 5714359-244554 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 733449 |
| Manufacturer | SYNOVIS SURGICAL INNOVATIONS |
| Manufacturer Address | 2575 UNIVERSITY AVE. ST. PAUL MN 55114 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-07-25 |