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 2008-01-16 for OLYMPUS A5294A manufactured by Olympus Winter & Ibe Gmbh.
[745984]
The user facility reported that after the procedure, it was noted that the patient sustained two second-degree burns under the patient's navel. The user facility claimed that the source of the burns came from the light cord used with the telescope, but the user also claimed that the heat originated from the telescope and not the light cord. The user also reported that the light cord was tested after the procedure and there was no problem found. A regular burn dressing was applied to the affected area and the patent was released from the facility the same day. The patient was reportedly doing fine.
Patient Sequence No: 1, Text Type: D, B5
[7930016]
The device referenced in this report was returned to olympus for investigation. The investigation confirmed that the light guide post of the telescope became hot after testing the telescope for an hour with the use of an olympus test light source and an olympus test light guide cable. The light guide post temperature was measured twice and the temperature readings were 44 & 38 degree celsius. In addition, the telescope had nicks and dents, and the outer tube was found sharp due to deep scratches. This phenomenon was isolated to physical damage and user handling. This report is being filed as an mdr in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610773-2008-00004 |
| MDR Report Key | 979913 |
| Report Source | 00,05,06 |
| Date Received | 2008-01-16 |
| Date of Report | 2007-12-18 |
| Date Added to Maude | 2008-10-01 |
| 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 | TELESCOPE |
| Product Code | FBP |
| Date Received | 2008-01-16 |
| Model Number | A5294A |
| 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 | 983791 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | HAMBURG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-16 |