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 VASOVIEW HEMOPRO 2 WITH VASOSHIELD VH-4001 manufactured by Maquet Cardiovascular, Llc.
[18087249]
The hospital reported that during an endoscopic vein harvesting procedure, the metal cautery part on the jaws of the vasoview hemopro 2 with vasoshield became detached. It was sticking in the middle between both jaws. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
Patient Sequence No: 1, Text Type: D, B5
[18552221]
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. A lot history record review was completed for the reported product lot number. There was no nonconformance recorded in the lot history. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2242352-2015-00123 |
| MDR Report Key | 4564369 |
| Report Source | 05,07 |
| Date Received | 2015-02-27 |
| Date of Report | 2015-02-05 |
| Date of Event | 2015-02-05 |
| Date Mfgr Received | 2015-02-05 |
| Device Manufacturer Date | 2015-10-01 |
| 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 | PHYSICIAN ASSISTANT |
| 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 | VASOVIEW HEMOPRO 2 WITH VASOSHIELD |
| Generic Name | ENDOSCOPIC VESSEL HARVESTINGQ |
| Product Code | OSV |
| Date Received | 2015-02-27 |
| Model Number | VH-4001 |
| Lot Number | 25104987 |
| Device Expiration Date | 2015-10-07 |
| 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 |