MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2015-10-09 for LIGHT GUIDE, SIZE M, PLUG TYPE, 3 M, CF TYPE WA03210A manufactured by Olympus Winter & Ibe Gmbh.
[27917603]
The light-guide cable was not returned to olympus for evaluation/investigation as there was no malfunction and the device is still being used by the user facility. However, as clearly stated as a warning note in the instructions, the telescope's distal end or the light-guide connector must not be placed on the patient's skin, on flammable materials or on heat-sensitive materials as otherwise there is a risk of thermal injury to the patient's tissue, burns to the patient's or user's skin or burns or thermal damage to surgical equipment. The user facility staff apparently did not follow these instructions as the patient reportedly sustained a second-degree burn on the thigh after the telescope connector of the light-guide cable was placed onto the medical drape sheet while the connected light source was already turned on. Therefore this event/incident was attributed to abnormal use/off-label use and the case will be closed from olympus side with no further actions. However, the event/incident will be recorded for trending and surveillance purposes and the user facility staff will be trained again on the correct usage of the olympus medical devices.
Patient Sequence No: 1, Text Type: N, H10
[27917604]
Olympus was informed that during or after an unspecified therapeutic procedure at unknown date, it was noticed that the patient sustained a second-degree burn on the thigh. Prior to this, the user facility staff reportedly placed the telescope connector of the light-guide cable onto the medical drape sheet while the connected light source was already turned on. No further information was provided but none of the olympus medical devices showed any malfunction and the intended procedure was reportedly completed with the same set of equipment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610773-2015-00047 |
| MDR Report Key | 5139877 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2015-10-09 |
| Date of Report | 2015-10-09 |
| Date Mfgr Received | 2015-10-06 |
| Date Added to Maude | 2015-10-09 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DANIEL WLADOW |
| Manufacturer Street | KUEHNSTRASSE 61 |
| Manufacturer City | HAMBURG, 22045 |
| Manufacturer Country | GM |
| Manufacturer Postal | 22045 |
| Manufacturer Phone | 40 66966 |
| Manufacturer G1 | GIKEN SAKATA (S) LIMITED |
| Manufacturer Street | BLK 4012 ANG MO KIO AVE 10 #05-01 TECHPLACE 1 |
| Manufacturer City | SINGAPORE, 569628 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 569628 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGHT GUIDE, SIZE M, PLUG TYPE, 3 M, CF TYPE |
| Generic Name | LIGHT GUIDE AND ACCESSORIES |
| Product Code | EWY |
| Date Received | 2015-10-09 |
| Catalog Number | WA03210A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2015-10-09 |