MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2011-12-08 for OLYMPUS ENDOSCOPES UNKNOWN manufactured by Olympus Medical Systems Corporation.
[20220778]
Olympus was informed that the user facility was not reprocessing the endoscopes in accordance with the directions for use. The user facility personnel were reportedly not performing any of the pre-cleaning steps, and was not leak testing. Additionally, the user facility reportedly was not using the suction cleaning adaptor and would reuse single-use cleaning brushes. The user facility reportedly was not using the channel opening brush and was not reprocessing the auxiliary water tube which reportedly was used in patient procedures for over one year without being reprocessed. The user facility reportedly did not have automated endoscope reprocessors on site with reprocessing performed only manually. There had been no report of infection and cross contamination.
Patient Sequence No: 1, Text Type: D, B5
[20591552]
An olympus endoscopy support specialist has visited this facility and provided in-service training and educational materials regarding the appropriate reprocessing of endoscopes. No products were returned to olympus for evaluation. If additional and significant information becomes available at a later time, then this report will be supplemented. Olympus instruction and reprocessing manuals provide detailed information on how to reprocess 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 | 8010047-2011-00309 |
| MDR Report Key | 2371695 |
| Report Source | 06,07 |
| Date Received | 2011-12-08 |
| Date of Report | 2011-11-09 |
| Date of Event | 2011-11-09 |
| Date Mfgr Received | 2011-11-09 |
| 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 |
| Health Professional | 0 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS ENDOSCOPES |
| Generic Name | ENDOSCOPE |
| Product Code | GDB |
| Date Received | 2011-12-08 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| 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 SYSTEMS CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-08 |