MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-02-25 for OLYMPUS EVIS EXERA COLONOVIDEOSCOPE CF-Q160AL NA manufactured by Olympus Medical Systems Corporation.
[1285636]
The user facility reported to have experienced a complete loss of image during a therapeutic colonoscopy. The users reported to have utilized a different, but similar device to complete the procedure. There was no pt injury associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[8449274]
The device referenced in this report was returned to olympus for eval. The eval confirmed the users' report of a complete loss of image. There was evidence of fluid inside the endoscope connector and control body unit. Additionally, there was no id data transmission from the device, and the light guide tube was buckled. The cause of the users' experience was determined to be due to user mishandling. The device has been refurbished. 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 | 8010047-2010-00031 |
| MDR Report Key | 1619424 |
| Report Source | 05,06 |
| Date Received | 2010-02-25 |
| Date of Report | 2010-01-27 |
| Date of Event | 2010-01-27 |
| Date Mfgr Received | 2010-01-27 |
| Date Added to Maude | 2010-08-19 |
| 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 | 2010-02-25 |
| Returned To Mfg | 2010-01-28 |
| Model Number | CF-Q160AL |
| 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 | 2010-02-25 |