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 2018-06-07 for EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPE SIF-H290S manufactured by Olympus Medical Systems Corp..
[110451130]
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. The malfunction of the subject device concerning this case has not been reported. The exact cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[110451131]
On may 11, 2018, olympus medical systems corp. (omsc) received a literature titled? Study on ercp(endoscopic retrograde cholangiography) using short- type single balloon endoscope(sbe) for patients who experienced rouen-y intestinal reconstructive surgery?. The literature reported the result of the 19 procedures of the ercp which were conducted between july 2016 and september 2017 at the user facility. In the 19 procedures, an olympus small intestinal videoscope sif-h290s was used. (however, in two of 19 procedure, olympus sif-q260 was used following the sif-h290s since the sif-h290s could not reach the target sites) the literature reported 3 case of mild pancreatitis as accidental symptoms related to the ercp procedures. In one of the 3 case of perforation, sif-h290s was apparently used. In the other two cases of perforation, sif-h290s and sif-q260 were possibly used. However, it was uncertain of whether the two scope were actually used in the two cases, and which scope attributed to the two perforations. According to the three accidental symptoms cases, omsc is submitting one medical device report (mdr) associated with sif-h290s and two mdrs associated with unspecified small intestine videoscope. This is two of three reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-01093 |
| MDR Report Key | 7580996 |
| Report Source | LITERATURE,USER FACILITY |
| Date Received | 2018-06-07 |
| Date of Report | 2018-06-08 |
| Date Mfgr Received | 2018-05-11 |
| Date Added to Maude | 2018-06-07 |
| 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 INTESTINAL VIDEOSCOPE |
| Product Code | FDA |
| Date Received | 2018-06-07 |
| Model Number | SIF-H290S |
| 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 | 2018-06-07 |