FDA Adverse Event
Injury
Summary report: N
VITRUOSAPH PLUS, EVH
MDR report key: 4101643
·
Received August 27, 2014
Report
- Report Number
- 1124841-2014-00132
- Event Type
- Injury
- Date Received
- August 27, 2014
- Date of Event
- August 12, 2014
- Report Date
- August 12, 2014
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- GCJ
- PMA / PMN Number
- K092789
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVAL; HOWEVER, AN INVESTIGATION HAD YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORP THAT DURING A VEIN HARVESTING DEMONSTRATION (USING SYNTHETIC MATERIAL), THE USER GOT A SMALL SHOCK WHILE ATTEMPTING TO USE THE VSP550. NO PT INVOLVEMENT. PRODUCT WAS CHANGED OUT. SURGERY WAS SUCCESSFULLY COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 522675 | VITRUOSAPH PLUS, EVH | LAPAROSCOPE, GENERAL | GCJ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | VSP550 | 41K |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |