MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2018-11-29 for EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPE SIF-H290S manufactured by Olympus Medical Systems Corp..
[128716655]
The subject device has 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. There was no malfunction report of the subject device concerning the events. The exact cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[128716656]
On november 2, 2018, olympus medical systems corp. (omsc) received a literature titled? Study on endoscopic treatment using short-type single balloon endoscope(short-sbe) for stenosis in postoperative choledochoduodenostomy? That was made in public in 26th japan digestive disease week. The literature reported the results and accidental symptoms in 34 procedures of short-sbe, in which balloon dilation using subject device were conducted for the stenosis. It was also reported that the 1 cases of accidental symptom (digestive perforation) occurred. Omsc reviewed the delivery history of the endoscopes and the history revealed that olympus small intestinalvideoscopes (model sif-h290s) had been delivered to the user facility. In the procedures, the sif-h290s and olympus single use splinting tubes (st-sb1s) were possibly used. Omsc tried to obtain additional information from the user facility, but additional information was not provided at present. Omsc is submitting one mdr according to the number of reported perforation case in each type of device (small intestinal videoscope and splinting tube).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-02318 |
| MDR Report Key | 8114370 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2018-11-29 |
| Date of Report | 2018-11-29 |
| Date Mfgr Received | 2018-11-02 |
| Date Added to Maude | 2018-11-29 |
| 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 ELITE SMALL INTESTINALVIDEOSCOPE |
| Generic Name | SMALL INTESTINALVIDEOSCOPE |
| Product Code | FDA |
| Date Received | 2018-11-29 |
| Model Number | SIF-H290S |
| 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 | 2018-11-29 |