D
Patient 1
WHILE SCANNING A PT USING THE VISANTE AC-OCT SYSTEM, THE TABLE SUPPORTING THE INSTRUMENT ALLEGEDLY MALFUNCTIONED CAUSING THE TABLE TOP TO GRAZE THE PT'S LEG. NO SERIOUS INJURY OCCURRED. THIS INCIDENT OCCURRED AT: (B)(6).
MAUDE MDR 2923294
- MDR report key
- 2923294
- Report number
- 2918630-2006-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 2006-08-25
- Date received
- 2006-09-21
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- KENT JONES
- Address
- 5160 HACIENDA DR. DUBLIN CA 94568 US
- Phone
- 925-925-9255
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | VISANTE | OPTICAL COHERENCE TOMOGRAPHY | CARL ZEISS MEDITEC INC | HLI | 1000 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2006-09-21 | 0 | 1. O |
Event Narratives#
N
Patient 1
ZEISS FIELD SERVICE REP CONFIRMED THAT THE VISANTE IS FUNCTIONING PROPERLY. HOWEVER, THE TABLE IS NOT FUNCTIONAL AND IS BEING RETURNED TO ZEISS FOR FURTHER EVAL.