MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-03-07 for OLYMPUS ENDOSCOPE ENDOCOPES UNK manufactured by Olympus Medical System Corp.
[2574029]
Olympus was informed that the user facility had not been reprocessing the auxiliary water channel of all their endoscopes for an unspecified period. There were no reports of any pt or user infections.
Patient Sequence No: 1, Text Type: D, B5
[9747717]
No devices were returned for evaluation. Based upon the information provided, the user facility was not reprocessing their endoscopes in accordance to the instructions for use. The user facility had been reprocessing the subject device in an automatic endoscopy preprocessor, but had not been reprocessing the auxiliary water channel. An olympus endoscope service specialist (ess) has visited the user facility, and provided in-service training regarding the appropriate reprocessing of endoscopes. The ess has also provided the user facility reprocessing dvd's and educational materials for additional reference. This report appears to be due to user error. 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 | 8010047-2012-00059 |
| MDR Report Key | 2507450 |
| Report Source | 06 |
| Date Received | 2012-03-07 |
| Date of Report | 2012-02-09 |
| Date Mfgr Received | 2012-02-09 |
| Date Added to Maude | 2012-05-24 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAURA STORMES-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 SYSTEM CORP |
| Manufacturer Street | 2951 ISHIKAWA-CHO HACHIOJI-SHI |
| Manufacturer City | TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 192-8507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS ENDOSCOPE |
| Generic Name | ENDOSCOPES |
| Product Code | GCQ |
| Date Received | 2012-03-07 |
| Model Number | ENDOCOPES |
| Catalog Number | UNK |
| Lot Number | NA |
| ID Number | NA |
| 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 SYSTEM CORP |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-07 |