MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2008-01-30 for OLYMPUS A50021A manufactured by Olympus Winter & Ibe Gmbh.
[798594]
The user facility returned the device to olympus for service. The device was received with a user's report of "no image and it burned a pt. " the user facility was contacted several times to obtain additional info regarding this report; however, no further info was obtained.
Patient Sequence No: 1, Text Type: D, B5
[7934524]
The device was returned to olympus national service center for service. The device was then forwarded to ra for investigation due to the nature of the user's report. The investigation confirmed the user's report of "no image. " the outer tube of the telescope was severely dented, bent and bore multiple scratches. The impacts to the outer tube appeared to have caused image problems and were determined to be due to physical damage. The eval did not duplicate the device becoming unusually warm. Olympus will continue to work with the user facility to obtain clarifying info regarding the pt's outcome. If additional and significant info becomes available at a later date, a supplemental report will follow. This report is being submitted as an mdr in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610773-2008-00009 |
| MDR Report Key | 988725 |
| Report Source | 00,05,06 |
| Date Received | 2008-01-30 |
| Date of Report | 2007-12-27 |
| Date Added to Maude | 2008-07-22 |
| 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 | 2008-01-30 |
| Model Number | A50021A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 989666 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | HAMBURG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-30 |