MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-12 for EVIS LUCERA XENON LIGHT SOURCE CLV-260 manufactured by Olympus Medical Systems Corp..
[114453082]
The subject clv-260 has not been returned to olympus medical systems corp. (omsc) yet. Omsc will investigate the subject clv-260 to identify the root cause of this failure phenomenon when omsc receives it. The exact cause of the reported event could not be conclusively determined at this time. There were no further details provided. If significant additional information is received, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[114453083]
Near the end of ercp, the facility tried to place the pancreatic stent in the patient's body. At that time, the endoscopic image displayed on an unspecified monitor was disappeared. The facility continued and completed the procedure without using the endoscopic image. But, the facility could not confirm whether the pancreatic stent was definitely placed in the patient's body. There was no report of the patient's injury regarding this event. At this time, the facility has no plan to perform the reoperation for the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-01320 |
| MDR Report Key | 7680575 |
| Date Received | 2018-07-12 |
| Date of Report | 2018-08-07 |
| Date of Event | 2018-06-19 |
| Date Mfgr Received | 2018-07-26 |
| Date Added to Maude | 2018-07-12 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR KAZUTAKA MATSUMOTO |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 426425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EVIS LUCERA XENON LIGHT SOURCE |
| Generic Name | XENON LIGHT SOURCE |
| Product Code | GCT |
| Date Received | 2018-07-12 |
| Model Number | CLV-260 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-12 |