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 2018-08-13 for LIGHT-GUIDE CABLE, 4.25 MM, 3 M, CF TYPE WA03310A manufactured by Olympus Winter & Ibe Gmbh.
[116852101]
The suspect medical device has not yet been returned to olympus for evaluation/investigation. Therefore, the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown. However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[116852102]
Olympus was informed that prior to a therapeutic total laparoscopic hysterectomy (tlh) procedure, the liner cloth caught fire after the light-guide cable was connected to the light source. For five to ten minutes the light source was in standby mode and the light-guide cable was not connected to the rigid scope. The fire of the liner cloth caused a third-degree burn close to the patient? S waist. An incision was made to remove the dead skin and the wound was sutured afterwards to close it. No further information was provided, but the intended procedure was then successfully completed with the same set of equipment.
Patient Sequence No: 1, Text Type: D, B5
[117868111]
Device evaluation: the suspect medical device was not returned to olympus for evaluation/investigation. The evaluation showed that the cause for this issue is most likely improper handling. There are caution notes in the instructions for use, which clearly state that light-guide cable connectors may become hot and should not be placed on the patient? S skin, on flammable materials, or on heat-sensitive materials. Hence the reported phenomenon does not represent a malfunction. Furthermore, a manufacturing and quality control review could not be performed since basic data of article identification (lot number) are missing. The case will be closed on olympus side with no further actions but the reported event/incident will be recorded for trending and surveillance purposes. Furthermore, the user will be informed about the investigation results and retrained to correctly use the olympus medical devices.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610773-2018-00072 |
| MDR Report Key | 7776104 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-08-13 |
| Date of Report | 2018-08-22 |
| Date of Event | 2018-08-02 |
| Date Mfgr Received | 2018-08-22 |
| Date Added to Maude | 2018-08-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | SCHOTT AG |
| Manufacturer Street | HATTENBERGSTRASSE 10 |
| Manufacturer City | MAINZ |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGHT-GUIDE CABLE, 4.25 MM, 3 M, CF TYPE |
| Generic Name | LIGHT GUIDE AND ACCESSORIES |
| Product Code | HBI |
| Date Received | 2018-08-13 |
| Model Number | WA03310A |
| Catalog Number | WA03310A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-13 |