MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-07-30 for OLYMPUS CF-Q180AL manufactured by Olympus Medical Systems Corporation.
[914362]
The user facility reported that during a diagnostic colonoscopy, the image froze and could not be recovered. The procedure was reportedly completed with a similar, but different device and there was no patient injury. No further detailed information was provided by the user facility.
Patient Sequence No: 1, Text Type: D, B5
[8109343]
The device referenced in this report was returned to olympus for investigation. The investigation confirmed the user's report of intermittent flickering and blacking out when the electrical connector was manipulated. There was corrosion found inside the electrical connector, micro connector, and the flexible printed circuit board terminals. The cause of the user's experience was determined to be due to fluid invasion. As the device passed the leak test, the source of the fluid invasion appears to be due to user mishandling. This report is being filed as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2008-00137 |
| MDR Report Key | 1096036 |
| Report Source | 06 |
| Date Received | 2008-07-30 |
| Date of Report | 2008-06-30 |
| Date of Event | 2008-07-08 |
| Date Added to Maude | 2009-04-15 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | 22-2 NISHI-SHINJUKU SHINJUKU-KU, 1-CHOME |
| Manufacturer City | TOKYO 163-91 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 163-91 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS |
| Generic Name | EVIS EXERA II COLONOVIDEOSCOPE |
| Product Code | FTJ |
| Date Received | 2008-07-30 |
| Model Number | CF-Q180AL |
| 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 SYSTEMS CORPORATION |
| Manufacturer Address | SHINJUKU-KU, 1-CHOME JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-30 |