FDA Adverse Event
Summary report: N
TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM
MDR report key: 2244002
·
Received August 30, 2011
Report
- Report Number
- 1124841-2011-00374
- Date Received
- August 30, 2011
- Date of Event
- August 10, 2011
- Report Date
- August 11, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- GCJ
- PMA / PMN Number
- K083194
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
TERUMO RECEIVED THE ACTUAL DEVICE, AND UPON EVALUATION THE COMPLAINT WAS NOT CONFIRMED; HOWEVER, TERUMO IS STILL INVESTIGATING THIS ISSUE AND WILL BE SUBMITTING A FOLLOW-UP REPORT WHEN MORE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING VEIN HARVESTING, THERE WAS AN INSUFFLATION PROBLEM WITH THE VIRTUOSAPH ENDOSCOPIC VEIN HARVESTING SYSTEM. THE PRODUCT WAS NOT CHANGED OUT. THERE WAS NO HARM TO PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM | VIRTUOSAPH DISPOSABLE | GCJ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | MCVS550 | 14K |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |