MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-09-30 for VASOVIEW 6 PRO VH-2400 manufactured by Maquet Cardiovascular Llc.
[16183901]
The hosp reported that during preparation for an endoscopic vein harvesting procedure, the bipolar bisector was inoperable "didn't work" lever didn't make blade work on the vasoview 6 pro. The device was not used on the pt. A replacement device was used to complete the procedure. The hosp did not report any pt effects.
Patient Sequence No: 1, Text Type: D, B5
[16440184]
The device has been returned to the factory and is being evaluated. A supplemental report will be submitted when the evaluation is completed. A lot history record review was completed for the reported product lot number. There was no nonconformance recorded in the lot history. There are no other similar complaints reported against this batch. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2242352-2014-01027 |
| MDR Report Key | 4139665 |
| Report Source | 05,07 |
| Date Received | 2014-09-30 |
| Date of Report | 2014-09-02 |
| Date of Event | 2014-08-26 |
| Date Mfgr Received | 2014-09-02 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2014-10-09 |
| 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 | 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 | 9737097690 |
| 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 | VASOVIEW 6 PRO |
| Generic Name | ENDOSCOPIC VESSEL HARVESTING |
| Product Code | OSV |
| Date Received | 2014-09-30 |
| Returned To Mfg | 2014-09-10 |
| Model Number | VH-2400 |
| Lot Number | 25097534 |
| Device Expiration Date | 2015-05-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOVASCULAR LLC |
| Manufacturer Address | WAYNE NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-30 |