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 2016-01-27 for LIGHT GUIDE, SIZE M, PLUG TYPE, 3 M, CF TYPE WA03210A manufactured by Olympus Winter & Ibe Gmbh.
[36890747]
The light-guide cables were not yet returned to the manufacturer 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 devices are returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[36890748]
Olympus was informed that during a therapeutic laparoscopic assisted distal gastrectomy (ladg) procedure, the endoscopic image became abnormally dark when the rigid endoscope was inserted into the patient's body cavity through a trocar tube. The surgical team then replaced the light-guide cable and the camera head, but the image remained dark. The intended procedure was subsequently canceled and converted to open surgery. No further information was provided and the patient's current condition and outcome is also unknown.
Patient Sequence No: 1, Text Type: D, B5
[38446794]
Device evaluation: the light-guide cable was not returned to the manufacturer for evaluation/investigation but to olympus medical systems corporation (omsc), (b)(4) (returned to omsc on 2016-02-04). The evaluation/investigation discovered broken light-guide fibers belonging to the optical fiber bundle which decreased light efficiency, and was caused by excessively bending, coiling or pulling the cable. This damage led to the reported phenomenon of an abnormally dark endoscopic image as there was considerably decreased light transmission/illumination. As clearly stated as a caution note in the instructions, the light-guide cable must not be coiled into a diameter smaller than 15 cm as otherwise there is a risk of damage, resulting in broken light-guide fibers and decreased light efficiency. Furthermore, it is pointed out as a caution note that the cable has to be plugged or unplugged by always pulling at the plug and never at the cable as otherwise there is a risk of damaging the cable. The user apparently did not follow these instructions, since the broken light-guide fibers were caused by excessively bending, coiling or pulling the cable. 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 informed about the investigation results and pro re nata retrained to correctly use the olympus medical devices.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610773-2016-00004 |
| MDR Report Key | 5392521 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2016-01-27 |
| Date of Report | 2016-01-27 |
| Date of Event | 2016-01-12 |
| Date Mfgr Received | 2016-02-05 |
| Device Manufacturer Date | 2013-09-01 |
| Date Added to Maude | 2016-01-27 |
| 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 | 2016-01-27 |
| Model Number | WA03210A |
| Catalog Number | WA03210A |
| Lot Number | 139W |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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, 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-01-27 |