MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-01-12 for OLYMPUS EVIS EXERA COLONOVIDEOSCOPE CF-Q160L NA manufactured by Olympus Medical Systems Corporation.
[1275564]
The user facility reported to have identified a recent cluster of clostridium difficile among nine pts that had undergone endoscopy procedures. Eight of the pts underwent colonoscopies, and one pt underwent a gastroscopy, between dates (b)(6)2009 and (b)(6)2009. One of the colonoscopy pts was reported to have been hospitalized for an unspecified amount of time. The nine affected pts have been notified and are reportedly doing fine. No further detailed info was provided by the user facility.
Patient Sequence No: 1, Text Type: D, B5
[8509999]
Olympus followed up with the user facility via phone and in writing to obtain additional detailed info regarding the event, however only limited detailed info has been received to date. An olympus endoscopy support specialist (ess) visited the user facility following the reported event to review and provide in-service training on reprocessing procedures as needed. No significant reprocessing deficiencies were noted during the ess visit. The colonoscope referenced in this report was sent to an independent laboratory for microbiological testing. While final test results have not yet been provided, the device referenced in this report tested positive for clostridium perfringens and enterococcus faecalis. The device was forwarded to olympus for eval following the laboratory microbiological testing. The eval found small amounts of white debris inside the channel mount unit, suction cylinder unit, and the inlet and proximal ends of the auxilliary water channel. The device will be serviced and returned to the customer. Olympus continues to investigate this report. If any significant additional info becomes available, a supplemental report will be provided. Cross-reference manufacturer report numbers 8010047-2010-00008 and 8010047-2010-00009 for the other associated 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 | 8010047-2010-00007 |
| MDR Report Key | 1579940 |
| Report Source | 05,06 |
| Date Received | 2010-01-12 |
| Date of Report | 2009-12-14 |
| Date Mfgr Received | 2009-12-14 |
| Date Added to Maude | 2010-03-03 |
| 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 | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI 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 EVIS EXERA COLONOVIDEOSCOPE |
| Generic Name | COLONOSCOPE |
| Product Code | FTJ |
| Date Received | 2010-01-12 |
| Returned To Mfg | 2010-01-12 |
| Model Number | CF-Q160L |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-01-12 |