MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2006-09-21 for VISANTE 1000 manufactured by Carl Zeiss Meditec Inc.
[19022473]
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).
Patient Sequence No: 1, Text Type: D, B5
[19289673]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2918630-2006-00002 |
| MDR Report Key | 2923294 |
| Report Source | 06,07 |
| Date Received | 2006-09-21 |
| Date of Report | 2006-09-21 |
| Date of Event | 2006-08-25 |
| Date Mfgr Received | 2006-08-25 |
| Device Manufacturer Date | 2006-08-01 |
| Date Added to Maude | 2013-01-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KENT JONES |
| Manufacturer Street | 5160 HACIENDA DR. |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal | 94568 |
| Manufacturer Phone | 9255574353 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISANTE |
| Generic Name | OPTICAL COHERENCE TOMOGRAPHY |
| Product Code | HLI |
| Date Received | 2006-09-21 |
| Model Number | 1000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC INC |
| Manufacturer Address | DUBLIN CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-09-21 |