MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-05-10 for OLYMPUS SIGMOIDOFIBERSCOPE OSF-3 manufactured by Olympus Medical Systems Corporation.
[2653626]
Olympus was informed that the user facility was not reprocessing the endoscope in accordance with the directions for use. The users were reportedly spraying only the endoscope with a disinfectant following the procedure, and drying the endoscope off prior to using again on another pt. There were no reports of any infections or other adverse impacts to pts.
Patient Sequence No: 1, Text Type: D, B5
[9849383]
Olympus contacted the user facility to obtain add'l info regarding the report and was informed that there was no pt infection or cross contamination associated with the report. The user facility staff mentioned that the subject device has been isolated since the olympus' endoscopy support specialist's (ess) visit. The subject device has not yet been returned to olympus for eval. The ess provided a reprocessing in-service to the user facility's staff on how to properly reprocess endoscopes. This report is being submitted as a medical device report in excess of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2012-00145 |
| MDR Report Key | 2577660 |
| Report Source | 06 |
| Date Received | 2012-05-10 |
| Date of Report | 2012-04-13 |
| Date Mfgr Received | 2012-04-13 |
| Date Added to Maude | 2012-05-31 |
| 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 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 SIGMOIDOFIBERSCOPE |
| Generic Name | SIGMOIDOSCOPE |
| Product Code | FAM |
| Date Received | 2012-05-10 |
| Model Number | OSF-3 |
| Catalog Number | OSF-3 |
| 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 | 2012-05-10 |