MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-06 for EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE SIF-Q180 manufactured by Olympus Medical Systems Corp..
[128264946]
The subject device in this report has not been returned to omsc for evaluation. Omsc reviewed the manufacture history of the device and confirmed no irregularity. The exact cause of the reported event could not be conclusively determined at this time. If additional information becomes available, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[128264947]
Olympus medical systems corp. (omsc) was informed that as a result of routine microbiological testing by the user facility, the sample collected from the all channels of the subject device tested positive for pantoea agglomerans (46cfu/endoscope). The device had been manually reprocessed using peracetic acid. There was no report of infection associated with this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-02125 |
| MDR Report Key | 8040738 |
| Date Received | 2018-11-06 |
| Date of Report | 2018-12-21 |
| Date of Event | 2018-09-05 |
| Date Mfgr Received | 2018-12-04 |
| Date Added to Maude | 2018-11-06 |
| 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 | 0 |
| Brand Name | EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE |
| Generic Name | SMALL INTESTINAL VIDEOSCOPE |
| Product Code | FDA |
| Date Received | 2018-11-06 |
| Model Number | SIF-Q180 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-06 |