MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-05-11 for OLYMPUS A50021A NA manufactured by Olympus Winter & Ibe Gmbh.
[17720785]
The user facility reported that during a therapeutic procedure, the users observed lines on the image. The procedure was reportedly completed with a different, but similar device and there was no pt injury. No further detailed info was provided by the user facility.
Patient Sequence No: 1, Text Type: D, B5
[17917875]
The device referenced in this report was returned to olympus for eval. The eval confirmed the user's report of lines on the image. The device was tested and the image was observed to be very distorted. The image difficulty was isolated to a damaged light guide cable. Additionally, there was a single piece of dust noted under the cover glass. The cause of the user's experience was attributed to excessive force on the light guide cable this report is being filed as a med device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610773-2009-00006 |
| MDR Report Key | 1465645 |
| Report Source | 06 |
| Date Received | 2009-05-11 |
| Date of Report | 2009-04-13 |
| Date Mfgr Received | 2009-04-13 |
| Date Added to Maude | 2010-02-17 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAURA STORMS-TYLER |
| Manufacturer Street | 2400 RINGWOOD AVE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Street | KUEHNSTRASSE 61 |
| Manufacturer City | HAMBURG 22045 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 22045 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS |
| Generic Name | VIDEO TELESCOPE |
| Product Code | FBP |
| Date Received | 2009-05-11 |
| Model Number | A50021A |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-05-11 |