MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-02-27 for VASO VIEW HEMOPRO manufactured by Maquet Cardiovascular, Llc.
[5475295]
The hospital reported that during an endoscopic vein harvesting procedure, the vaso view hemopro starting smoking prior to the trigger being accelerated. It was observed in the tunnel and was immediately removed and disconnected. The hospital did not report any patient effects.
Patient Sequence No: 1, Text Type: D, B5
[12998187]
The device has not yet been returned to maquet cardiac surgery for evaluation. We are following up with the customer for the return of the device. A supplemental report will be submitted if the device is received. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2242352-2015-00203 |
| MDR Report Key | 4564311 |
| Report Source | 05,07 |
| Date Received | 2015-02-27 |
| Date of Report | 2015-02-02 |
| Date of Event | 2015-02-02 |
| Date Mfgr Received | 2015-02-02 |
| Date Added to Maude | 2015-04-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TINA EVANCHO |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer Phone | 9737097265 |
| Manufacturer G1 | MAQUET CARDIOVASCULAR, LLC |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07470 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VASO VIEW HEMOPRO |
| Generic Name | ENDOSCOPIC VESSELS HARVESTING |
| Product Code | OSV |
| Date Received | 2015-02-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOVASCULAR, LLC |
| Manufacturer Address | WAYNE NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-27 |