MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-15 for LIGHT-GUIDE CABLE, 4.25 MM, 3 M, CF TYPE WA03310A manufactured by Olympus Winter & Ibe Gmbh.
[77787370]
The device was not returned to olympus for evaluation. The cause of the reported event could not be conclusively determined, however, the most probable cause of the reported event can be attributed to operational error. The instruction manual provides caution statements which states; light sources emit large amounts of energy. As a result the connectors of the endoscopic equipment and the distal end of the endoscope become hot. There is a risk of thermal injury to the patient? S tissue (e. G. , from prolonged exposure to the intense illumination in cavities with small lumens, or if the distal end of the endoscope is placed into close proximity to the tissue), burns to the patient? S or user? S skin, burns or thermal damage to surgical equipment (e. G. , surgical drapes, plastic materials). Do not place the endoscopic equipment on the patient? S skin, on flammable materials, or on heat-sensitive materials. Set the output power of the light source to the minimum level that is necessary for a sufficient illumination of the target area. Avoid prolonged exposure to intense illumination. Switch off the light source or set the light source to standby mode whenever the light source is not in use. If additional information becomes available or if the device is returned for evaluation at a later date, this report will be supplemented accordingly. The original equipment manufacturer (oem) performed a dhr review with the reported lot number and revealed no deviations regarding the function and safety of the device.
Patient Sequence No: 1, Text Type: N, H10
[77787371]
Olympus was informed that the light guide cable smoked when connected to the light source and then caught fire during an unspecified procedure. There was no patient or user injury reported. The user facility indicated that the light guide cable will be returned to olympus for evaluation, but no further information provided.
Patient Sequence No: 1, Text Type: D, B5
[81058028]
The device was returned to olympus for evaluation. The evaluation confirmed the reported event. The evaluation found the internal light guide fiber bundles were completely detached near the light source connector side. There is a kink at the breakage area and which was noticeably discolored. When the light cable was connected to a light source, it revealed the light would transmit and stop at the location of the light guide fiber separation, resulting in the insulation to overheat due to prolonged exposure from the intense illumination.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2017-00411 |
| MDR Report Key | 6645365 |
| Date Received | 2017-06-15 |
| Date of Report | 2017-07-13 |
| Date of Event | 2017-05-25 |
| Date Mfgr Received | 2017-06-28 |
| Device Manufacturer Date | 2015-09-01 |
| Date Added to Maude | 2017-06-15 |
| 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 | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 408935-512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LIGHT-GUIDE CABLE, 4.25 MM, 3 M, CF TYPE |
| Generic Name | LIGHT-GUIDE CABLE, 4.25 MM, 3 M, CF TYPE |
| Product Code | GCT |
| Date Received | 2017-06-15 |
| Model Number | WA03310A |
| Catalog Number | WA03310A |
| Lot Number | 155W0004 |
| ID Number | 04042761082303 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG, HAMBURG 22045 GM 22045 |
| Brand Name | LIGHT-GUIDE CABLE, 4.25 MM, 3 M, CF TYPE |
| Generic Name | LIGHT-GUIDE CABLE, 4.25 MM, 3 M, CF TYPE |
| Product Code | HBI |
| Date Received | 2017-06-15 |
| Returned To Mfg | 2017-06-23 |
| Model Number | WA03310A |
| Catalog Number | WA03310A |
| Lot Number | 155W0004 |
| ID Number | 04042761082303 |
| Device Availability | R |
| 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, HAMBURG US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-15 |