MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature,user facility report with the FDA on 2020-03-06 for EVIS LUCERA DUODENOVIDEOSCOPE JF-260V manufactured by Olympus Medical Systems Corp..
[182294025]
The subject device was not returned to olympus medical systems corp (omsc). The malfunction of the subject device concerning this case has not been reported. The exact cause could not be determined. If additional information becomes available, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[182294026]
Olympus medical systems corp. (omsc) received a literature titled? Natural history of asymptomatic bile duct stones and association of endoscopic treatment with clinical outcomes?. The literature reported the result of 77 cases of the early endoscopic stone removal of asymptomatic stones procedures using olympus duodenovideoscope model jf-260v or tjf-260v or non-olympus endoscope from january 2010 to march 2018. In the subject cases, 3 case of bleeding, 3 cases of aspiration pneumonia and 1 case of gastrointestinal perforation occurred. Based on the available information, a direct relationship between the olympus products and the observed adverse events could not be determined. Therefore, omsc will submit 14 medical device reports (mdr) depending on the type of device and number of adverse events. This report is 3 of 14 reports for bleeding (3 of 3) at jf-260v.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2020-01672 |
| MDR Report Key | 9796970 |
| Report Source | LITERATURE,USER FACILITY |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2020-03-06 |
| 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 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 | 3 |
| Brand Name | EVIS LUCERA DUODENOVIDEOSCOPE |
| Generic Name | DUODENOVIDEOSCOPE |
| Product Code | FDT |
| Date Received | 2020-03-06 |
| Model Number | JF-260V |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-06 |