MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-01-29 for OLYMPUS EVIS EXERA II COLONOVIDEOSCOPE CF-H180AL NA manufactured by Olympus Medical Systems Corporation.
[14873588]
The user facility reported that a patient had sustained chemical colitis following a diagnostic colonoscopy. The patient was reported to have returned to the hospital within 24 hours of the procedure, with symptoms of chills, fever, and rectal bleeding. The patient was given antibiotics, but there was no improvement. A ct scan was performed and revealed significant thickening in the colon. Additionally, a blood test was said to have shown an increase in white blood cell count. The patient was diagnosed with colitis, given intravenous antibiotics and hospitalized for 3-4 days. The patient was reportedly doing fine upon release from the hospital.
Patient Sequence No: 1, Text Type: D, B5
[15452350]
Olympus followed up on this report and dispatched an olympus endoscopy support specialist (ess) and olympus field service engineer (fse) to visit the user facility and assess the user facility's reprocessing practices. During the visit, the users were found to have deviated from some of the recommended steps in reprocessing of the endoscope, and in the use of the chemical sterilant. The olympus representatives provided the educational materials and in-service training on the appropriate reprocessing procedures. The device referenced in this report was not returned to olympus for evaluation. The cause of the patient's outcome cannot be conclusively determined. However, improper reprocessing practices cannot be ruled out as a contributory factor. 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 | 8010047-2010-00016 |
| MDR Report Key | 1592143 |
| Report Source | 05,06 |
| Date Received | 2010-01-29 |
| Date of Report | 2010-01-04 |
| Date of Event | 2009-12-21 |
| Date Mfgr Received | 2010-01-04 |
| Date Added to Maude | 2011-03-16 |
| 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 II COLONOVIDEOSCOPE |
| Generic Name | COLONOSCOPE |
| Product Code | FTJ |
| Date Received | 2010-01-29 |
| Model Number | CF-H180AL |
| Catalog Number | NA |
| 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 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-01-29 |