FDA Adverse Event
Summary report: N
TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM
MDR report key: 2222702
·
Received July 7, 2011
Report
- Report Number
- 1124841-2011-00314
- Date Received
- July 7, 2011
- Date of Event
- June 20, 2011
- Report Date
- June 24, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
- Product Code
- GCJ
- PMA / PMN Number
- K083194
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVALUATION; THEREFORE, TERUMO IS STILL INVESTIGATING THIS ISSUE, AND WILL BE SUBMITTING A FOLLOW-UP REPORT WHEN MORE INFO IS AVAILABLE. (B)(4).
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING VEIN HARVESTING, THE INSUFFLATION FOR THE VEIN HARVESTER STOPPED WORKING. THE PRODUCT WAS CHANGED OUT. THERE WAS NO HARM TO PT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM | VIRTUOSAPH DISPOSABLE | GCJ | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION | MCVS550 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |