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 2007-10-24 for OLYMPUS CF-Q160L manufactured by Olympus Medical Systems Corporation.
[743661]
The hosp reported that they experienced a total loss of image during a diagnostic colonoscopy. The procedure was completed with a different, but similar device. There was no pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[7877284]
The device referenced in this report was returned to olympus for investigation. The investigation did not duplicate the user's report of image difficulty. The colonoscope was tested for more than four hours while the bending section was soaked in warm water, and the colonoscope was also tested with two different video processors and light sources and the image seemed to work appropriately. The colonoscope passed the fog test, and the leak test. The charge coupled device (ccd) resistance values were within the specs. There was no evidence of fluid invasion in the colonoscope. The cause of the user's experience cannot be conclusively determined at this time. This report is being filed as an mdr in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2007-00165 |
| MDR Report Key | 931714 |
| Report Source | 00,05,06 |
| Date Received | 2007-10-24 |
| Date of Report | 2007-09-25 |
| Date of Event | 2007-09-24 |
| Date Added to Maude | 2007-12-14 |
| 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 | 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 | 2007-10-24 |
| Model Number | CF-Q160L |
| 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 | 931161 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | SHINJUKU-KU 1-CHOME TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-24 |