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 2017-03-31 for LIGHT GUIDE, SIZE S, PLUG TYPE, 3 M, CF TYPE WA03200A manufactured by Olympus Winter & Ibe Gmbh.
[71392759]
There was no device returned to olympus for evaluation/investigation since the relevant light-guide cable could not be identified at the user facility. Furthermore, a manufacturing and quality control review could not be performed since basic data of article identification (lot number) are missing. 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 burn on the skin after the telescope connector of the light-guide cable was placed onto the medical drape sheet while the connected light source was switched 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 will be retrained to correctly use the olympus medical devices.
Patient Sequence No: 1, Text Type: N, H10
[71392760]
Olympus was informed that after an unspecified therapeutic surgical procedure, it was noticed that the patient had sustained a burn of approx. 1 cm in size on the skin. Prior to this, the user facility staff reportedly placed the telescope connector of the light-guide cable for about seven minutes onto the medical drape sheet while the connected light source was switched on. No further information was provided but there was no malfunction of the device. The patient was hospitalized and scheduled for an appointment with a dermatologist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610773-2017-00051 |
| MDR Report Key | 6448954 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-03-31 |
| Date of Event | 2017-03-16 |
| Date Mfgr Received | 2017-03-16 |
| Date Added to Maude | 2017-03-31 |
| 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 | 4940669662 |
| 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 S, PLUG TYPE, 3 M, CF TYPE |
| Generic Name | LIGHT GUIDE AND ACCESSORIES |
| Product Code | EWY |
| Date Received | 2017-03-31 |
| Model Number | WA03200A |
| Catalog Number | WA03200A |
| ID Number | 04042761051200 |
| 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. Hospitalization; 2. Required No Informationntervention | 2017-03-31 |