MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-03-08 for OLYMPUS ENDOSCOPES EDOSCOPES manufactured by Olympus Medical Systems Corporation.
[1434368]
Olympus was informed that user facility personnel were performing manual cleaning of endoscopes, but not appropriately pre-cleaning, brushing or flushing the channels of the subject device, nor sufficiently rinsing following disinfection. Furthermore, the users at the facility were reportedly not soaking the entire endoscope into the disinfectant solution. To date, there have been no reports of adverse events associated with this report.
Patient Sequence No: 1, Text Type: D, B5
[8447247]
No devices were returned to olympus for eval in association with this report. There was no allegation of any deficiencies in the product which may have caused or contributed to this report. Based upon the info provided, the users were not reprocessing the devices in accordance with the device instruction manual. An olympus endoscopy support specialist has provided in-service training and educational materials to the user facility staff on appropriate reprocessing of endoscopes. This report is being submitted as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2010-00041 |
| MDR Report Key | 1631235 |
| Report Source | 05,06 |
| Date Received | 2010-03-08 |
| Date of Report | 2010-02-08 |
| Date Mfgr Received | 2010-02-08 |
| Date Added to Maude | 2011-03-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAURA STORMS-TYLER |
| Manufacturer Street | 2400 RINGWOOD AVE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Street | 22-2 NISHI-SHINJUKU SHINJUKU-KU, 1-CHOME |
| Manufacturer City | TOKYO 163-91 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 163-91 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS ENDOSCOPES |
| Generic Name | ENDOSCOPES |
| Product Code | GDB |
| Date Received | 2010-03-08 |
| Model Number | EDOSCOPES |
| Lot Number | UNK |
| 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 CORPORATION |
| Manufacturer Address | 22-2 NISHI-SHINJUKU SHINJUKU-KU, 1-CHOME TOKYO 163-91 JA 163-91 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-03-08 |