MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-09 for EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE SIF-Q180 manufactured by Olympus Medical Systems Corp..
[125288030]
The subject device has not been returned to omsc. Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity. The exact cause could not be determined at present. If significant additional information is received, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[125288031]
Olympus medical systems corp. (omsc) was informed that during routine surveillance culturing tests at the user facility on august 21, 2018, the subject device tested positive for enterobacter cloacae (9cfu/85ml). It was also informed that the subject device tested repeatedly positive for enterobacter cloacae during additional culturing test at the user facility on august 27, 2018 as follows: the instrument channel: enterobacter cloacae (3cfu/50ml), the air/water channel: enterobacter cloacae (36cfu/50ml). In the culturing test august 27, 2018, the test result indicated no microbial growth for the suction channel. The subject device had been reprocessed using non-olympus automated endoscope reprocessor (soluscope s4) with peracetic acid. There was no report of patient infection associated with the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-01939 |
| MDR Report Key | 7946205 |
| Date Received | 2018-10-09 |
| Date of Report | 2018-11-12 |
| Date of Event | 2018-08-27 |
| Date Mfgr Received | 2018-10-15 |
| Device Manufacturer Date | 2010-08-04 |
| Date Added to Maude | 2018-10-09 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | 2018-10-09 |
| 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 | 2018-10-09 |