MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-06-01 for OLYMPUS ENDOSCOPES UNK manufactured by Olympus Medical Systems Corporation.
[2789762]
Olympus was informed that the user facility was not reprocessing their endoscopes in accordance with the directions for use. The users were reportedly not performing bedside cleaning immediately after each procedures, and not fully immersing the scope in the disinfectant solution. There were no reports of any pt infections or cross contamination.
Patient Sequence No: 1, Text Type: D, B5
[9829636]
There was no device returned to olympus for evaluation. Based upon the info provided, the user facility was not reprocessing their endoscopes in accordance to the instructions for use. The user facility had not been reprocessing the endoscopes in an automated endoscope preprocessor (aer) but the user facility was reportedly soaking their endoscopes in (b)(4), but the endoscope was not entirely immersed in the disinfectant solution due to the cylinder they used. An olympus endoscope support specialist (ess) has visited the user facility and provided in-service training to the user facility personnel regarding the appropriate reprocessing, transport and storage of endoscope. The ess has also provided the user facility reprocessing educational materials for additional references. 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 | 8010047-2012-00170 |
| MDR Report Key | 2598677 |
| Report Source | 06 |
| Date Received | 2012-06-01 |
| Date of Report | 2012-05-03 |
| Date Mfgr Received | 2012-05-03 |
| Date Added to Maude | 2012-06-15 |
| 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 AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, 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 ENDOSCOPES |
| Generic Name | ENDOSCOPES |
| Product Code | GDB |
| Date Received | 2012-06-01 |
| Model Number | ENDOSCOPES |
| Catalog Number | UNK |
| Lot 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 SYSTEMS CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-01 |