MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-18 for VIRTUOSAPH ENDOSCOPIC VEIN HARVESTING SYSTEM MCVS550 manufactured by Terumo Cardiovascular Systems Corp.
[45379021]
Patient Sequence No: 1, Text Type: N, H10
[45379022]
As the pa (physician assistant) was dissecting the vein using the terumo endoscopic vein harvest system ref# mcvs550 and lot# 57k and exp. 8/2018, it was noted that the "locking shaft" on the bipolar dissector was disconnected, which is not normal. The system was subsequently removed from the patient and a new system opened. No injury was noted by the p. A. To the patient, other than a slight delay caused by opening a new system. Both the bipolar dissector and the cone dissector (the entire package contents) were saved, along with the outer packaging, and sent to biomed for further evaluation. Manufacturer response for vein harvesting system, virtuosaph vein harvesting (per site reporter): none.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5662266 |
| MDR Report Key | 5662266 |
| Date Received | 2016-05-18 |
| Date of Report | 2016-05-04 |
| Date of Event | 2016-05-02 |
| Report Date | 2016-05-04 |
| Date Reported to FDA | 2016-05-04 |
| Date Reported to Mfgr | 2016-05-04 |
| Date Added to Maude | 2016-05-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIRTUOSAPH ENDOSCOPIC VEIN HARVESTING SYSTEM |
| Generic Name | ENDOSCOPIC VEIN HARVESTER |
| Product Code | OSV |
| Date Received | 2016-05-18 |
| Catalog Number | MCVS550 |
| Lot Number | 57K |
| Device Expiration Date | 2018-08-01 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORP |
| Manufacturer Address | 125 BLUE BALL ROAD ELKTON MD 21921 US 21921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-18 |