MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-05 for UNKNOWN manufactured by Olympus Medical Systems.
[95081957]
The subject device has not been returned to omsc for evaluation. Because the model name and serial number of this device are unknown, omsc couldn? T confirm the manufacturing history of this device. The user facility reported that they carried out precleaning and brushing of this device after procedure and there was no irregularity in leakage testing. The exact cause of the reported event could not be conclusively determined at this time. If additional information is received, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[95081958]
Olympus medical systems corp. (omsc) was informed that as a result of microbiological testing by the user facility, the back side of the angulation control knob of the subject device tested positive for gram-negative bacillus (1cfu). This device had been reprocessed using an olympus automated endoscope reprocessor model oer-3(not available in the usa). There was no report of patient infection associated with this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-01912 |
| MDR Report Key | 7085626 |
| Date Received | 2017-12-05 |
| Date of Report | 2017-12-06 |
| Date of Event | 2017-11-17 |
| Date Mfgr Received | 2017-11-16 |
| Date Added to Maude | 2017-12-05 |
| 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 KATSUAKI MORITA |
| 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 | UNKNOWN |
| Generic Name | UNKNOWN |
| Product Code | NWB |
| Date Received | 2017-12-05 |
| Model Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-05 |