MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-06-05 for OLYMPUS VIDEO TELESCOPE WA50023B manufactured by Olympus Winter & Ibe Gmbh.
[17185331]
Olympus followed up with the user facility via telephone and in writing to obtain more detailed information regarding the report, but with no result. The device referenced in this report was returned to olympus for evaluation. The evaluation confirmed the user's experience of image loss. The device outer tube was bent and had multiple dents. The device failed the transmission test. The image difficulty was attributed to damaged cable unit. The device will be refurbished. This report is being submitted as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[17198281]
The user facility reported that during an unspecified procedure, the video image turned black. There was no further information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610773-2012-00026 |
| MDR Report Key | 2617448 |
| Report Source | 99 |
| Date Received | 2012-06-05 |
| Date of Report | 2012-05-07 |
| Date Mfgr Received | 2012-05-07 |
| Date Added to Maude | 2012-10-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 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 VIDEO TELESCOPE |
| Generic Name | VIDEO TELESCOPE |
| Product Code | FBP |
| Date Received | 2012-06-05 |
| Returned To Mfg | 2012-05-07 |
| Model Number | WA50023B |
| Catalog Number | WA50023B |
| 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 | 2012-06-05 |