MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-08-21 for OLYMPUS A50021A manufactured by Olympus Winter & Ibe Gmbh.
[3050343]
The user facility reported that during an unspecified procedure, the image was lost. No further info was provided.
Patient Sequence No: 1, Text Type: D, B5
[10034436]
Olympus contacted the user facility via telephone and in writing to obtain more detailed info regarding this report, but with no result. The device referenced in this report was returned to olympus for eval. The eval confirmed the user? S experience of image loss. The device was tested for two hours when the image turned completely white, and there were horizontal lines that appeared on the video screen and flickering of image was also noted. Further investigation of the device confirmed that the image difficulty was attributed to a damaged video cable. The video cable was replaced and the video telescope was returned to the user facility. This report is being submitted as a medical device report in an excess of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610773-2012-00100 |
| MDR Report Key | 2717017 |
| Report Source | 06 |
| Date Received | 2012-08-21 |
| Date of Report | 2012-07-26 |
| Date Mfgr Received | 2012-07-26 |
| Date Added to Maude | 2012-10-15 |
| 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 AVENUE |
| 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 |
| Manufacturer Country | GM |
| 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 | 2012-08-21 |
| Returned To Mfg | 2012-07-31 |
| Model Number | A50021A |
| Catalog Number | A50021A |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-21 |