MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2007-11-20 for OLYMPUS CF-Q160AL manufactured by Olympus Medical Systems Corporation.
[750563]
The user facility reported that on two occasions, they experienced a total loss of video image. Facility staff stated, that when the colonoscope's right/left control knob was being torqued, colored lines appeared on the video screen resulting in a total loss of image. The physician withdrew the colonoscope from the patients and completed the procedures with a different, but similar devices. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[7902451]
The device referenced in this report was returned to olympus for investigation. The investigation found a light scratch on the objective lens, and particulates under the lens, but did not duplicate the user's report of loss of image. The device was returned unserviced at the user's request. This report is being submitted as an mdr in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2007-00181 |
| MDR Report Key | 950344 |
| Report Source | 00,05,06 |
| Date Received | 2007-11-20 |
| Date of Report | 2007-11-12 |
| Date Added to Maude | 2008-01-25 |
| 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 STORM-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 | 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 | COLONOSCOPE |
| Product Code | FTJ |
| Date Received | 2007-11-20 |
| Model Number | CF-Q160AL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 948903 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | SHINJUKU-KU, 1-CHOME TOKYO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-11-20 |