FDA Adverse Event
Summary report: N
TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM
MDR report key: 2001858
·
Received February 21, 2011
Report
- Report Number
- 1124841-2011-00050
- Date Received
- February 21, 2011
- Date of Event
- February 1, 2011
- Report Date
- February 1, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- GCJ
- PMA / PMN Number
- K031891
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR INVESTIGATION. TERUMO PLANS ON SUBMITTING A F/U REPORT WHEN THE INVESTIGATION IS COMPLETED AND MORE INFO BECOMES AVAILABLE. FOR THIS REASON, TERUMO REFERENCES EVAL CODES. (B)(4).
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING CLEANING THEY DISCOVERED THE ENDOSCOPE WAS BLURRY. THERE WAS NO PT INVOLVEMENT AS THIS OCCURRED DURING CLEANING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM | ENDOSCOPE | GCJ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | MCENDO550R | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |