MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-03-31 for OLYMPUS TELESCOPES A22001A UNK manufactured by Olympus Winter & Ibe Gmbh.
[1945332]
Olympus was informed that during an unspecified procedure, there was a popping sound and the image went black.
Patient Sequence No: 1, Text Type: D, B5
[9034425]
Olympus followed-up with the user facility to gather add'l info regarding this report via phone and in writing without success. No further details were provided. The device referenced in this report was returned to olympus for eval. The eval found the outer tube was critically bent by the direction pin. There were minor scratches and dent marks around the distal tip and on the objective frame. Additionally, it was noted that the optical lens was broken. The cause of the reported phenomenon could not be conclusively determined at this time. If add'l info becomes available at a later time, then this report will be supplemented. This report is being submitted as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610773-2011-00010 |
| MDR Report Key | 2072813 |
| Report Source | 06 |
| Date Received | 2011-03-31 |
| Date of Report | 2011-03-01 |
| Date of Event | 2011-03-01 |
| Date Mfgr Received | 2011-03-01 |
| Date Added to Maude | 2011-05-12 |
| 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 | 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 TELESCOPES |
| Generic Name | TELESCOPE |
| Product Code | FBP |
| Date Received | 2011-03-31 |
| Returned To Mfg | 2011-03-09 |
| Model Number | A22001A |
| Catalog Number | UNK |
| 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 | 2011-03-31 |