FDA Adverse Event
Summary report: N
TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM
MDR report key: 2222734
·
Received July 11, 2011
Report
- Report Number
- 1124841-2011-00306
- Date Received
- July 11, 2011
- Date of Event
- June 20, 2011
- Report Date
- June 21, 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
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVALUATION; THEREFORE, THE INVESTIGATION HAS NOT BEEN COMPLETED. TERUMO 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 PROCEDURE, THE ENDOSCOPE WAS BLURRY. 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 | ENDOSCOPE | GCJ | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION | MCENDO550R | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |