MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2011-06-30 for OLYMPUS EVIS EXERA COLONOVIDEOSCOPE CF-Q160L manufactured by Olympus Medical System Corporation.
[2123353]
Olympus was informed that during an unspecified type of colonoscopy procedure, the image quality developed lines and snow to the extent the users could no longer visualize the patient's anatomical structures. The intended procedure was completed with a different olympus endoscope. There was no patient harm reported.
Patient Sequence No: 1, Text Type: D, B5
[9192940]
Olympus followed-up with the user facility to gather additional information regarding this report. The user facility reported that the image became intermittent, developed horizontal and vertical lines, and the remaining image was snowy when the subject device reached the cecum. The users reportedly attempted to troubleshoot without success. The device reference in this report was returned to olympus for evaluation. The evaluation confirmed that the image on the scope was found flickering intermittently when the bending section was manipulated. The cause of the phenomenon was isolated to the ccd unit. The unit was serviced and returned to the user facility. 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 | 8010047-2011-00144 |
| MDR Report Key | 2160493 |
| Report Source | 06,07 |
| Date Received | 2011-06-30 |
| Date of Report | 2011-06-01 |
| Date of Event | 2011-06-01 |
| Date Mfgr Received | 2011-06-01 |
| Date Added to Maude | 2011-08-22 |
| 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 AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | OLYMPUS MEDICAL SYSTEM 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 EVIS EXERA COLONOVIDEOSCOPE |
| Generic Name | COLONOSCOPE |
| Product Code | FTJ |
| Date Received | 2011-06-30 |
| Returned To Mfg | 2011-06-01 |
| Model Number | CF-Q160L |
| Lot 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 SYSTEM CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-30 |