MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-03-11 for OLYMPUS OES 4000 TELESCOPE A1931A manufactured by Olympus Winter & Ibe Gmbh.
[17606884]
The user facility returned the subject device and the associated devices to olympus for inspection due to an unspecified pt incident.
Patient Sequence No: 1, Text Type: D, B5
[17645802]
Olympus followed up with the user facility and was informed that a pt expired during an unspecified procedure where olympus equipment was used. No further information was provided. The subject device and associated devices were returned to olympus for eval. The eval on the subject device noted a shadow and blur on the image due to a cracked optical system lens, and debris underneath the optical system lens. In addition, the outer tube was slightly bent, which is attributed to physical damage. The returned devices were tested as a system and no malfunctions were noted. The devices were returned to the user facility unrepaired per the user facility's request. The exact cause of the pt outcome remains unk. This report will be supplemented if additional and significant information becomes available at a later time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610773-2013-00026 |
| MDR Report Key | 3019494 |
| Report Source | 06 |
| Date Received | 2013-03-11 |
| Date of Report | 2013-02-12 |
| Date Mfgr Received | 2013-02-12 |
| Date Added to Maude | 2013-03-26 |
| 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 OES 4000 TELESCOPE |
| Generic Name | TELESCOPE |
| Product Code | FBP |
| Date Received | 2013-03-11 |
| Returned To Mfg | 2013-02-12 |
| Model Number | A1931A |
| Catalog Number | A1931A |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 1. Death | 2013-03-11 |