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 2019-12-12 for EVIS LUCERA SMALL INTESTINAL VIDEOSCOPE SIF-Q260 manufactured by Olympus Medical Systems Corp..
[185200489]
The subject device was not been returned to olympus medical systems corp (omsc). Omsc could not review the service and manufacturing record because the serial number was not provided from the facility. As part of our investigation, omsc reviewed all of the complaints for the period, but there was no record associated with the event described in the article. The exact cause of the reported event could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
[185200490]
Olympus medical systems corp. (omsc) was received jddw (japan digestive disease week) literature abstract that stated the result of the endoscopic treatment for bile duct stones using with sbe-ercp (endoscopic retrograde cholangiopancreatography using with single balloon endoscope) and ultrasound endoscope to the patients whom had experienced intestinal reconstructive surgery. The literature abstract reported the result of the ercp procedures for bile duct stones in 117 cases from april 2011 to march 2019. As accidental symptoms, the pancreatitis occurred in 5 cases after the ercp procedures, the small perforation occurred in 1 case during the pre-cut. The each patients were treated conservatively. The intestinal perforation occurred in 2 cases and it required the open abdominal surgery. Based on the available information, a direct relationship between the olympus product and the observed adverse events could not be determined. Omsc is submitting mdr according to the number of types of the accidental symptom. This is 4 of 8 reports. (4 of 5 pancreatitis cases).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2019-04293 |
| MDR Report Key | 9462807 |
| Report Source | LITERATURE,USER FACILITY |
| Date Received | 2019-12-12 |
| Date of Report | 2019-12-13 |
| Date Mfgr Received | 2019-11-21 |
| Date Added to Maude | 2019-12-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 SMALL INTESTINAL VIDEOSCOPE |
| Generic Name | SMALL INTESTINAL VIDEOSCOPE |
| Product Code | FDA |
| Date Received | 2019-12-12 |
| Model Number | SIF-Q260 |
| 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 | 2019-12-12 |