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.
[18512350]
The user facility reported that a pt was examined for pancolitis after undergoing a colonoscopy. The facility was contacted for add'l info, but no further info has been provided.
Patient Sequence No: 1, Text Type: D, B5
[18590976]
The device referenced in this report was returned to olympus for investigation. The biopsy channel and suction channel of the device was examined and the investigation revealed an identified reddish stain on the biopsy channel wall near the channel opening at the distal end. Similar staining was noted on the objective lens glue, light guide lens glue, air/water nozzle, auxiliary water tip opening and the bending section cover glue. In addition, there was yellow staining observed at the bending section cover and variable stiffness controls. These findings appear to be due to insufficient reprocessing of the device. Further investigation of the device noted that the air/water nozzle was deformed, and there were buckles and discoloration observed on the insertion tube. The device was serviced and returned to the facility. An olympus endoscopy support specialist will be visiting the facility to provide educational materials and information regarding appropriate endoscope reprocessing as needed. This report is being filed as an mdr in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2007-00184 |
| MDR Report Key | 950234 |
| Report Source | 00,05,06 |
| Date Received | 2007-11-20 |
| Date of Report | 2007-10-25 |
| Date Added to Maude | 2007-11-26 |
| 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 | 2007-11-20 |
| 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 | 923130 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | SHINJUKU-KU 1-CHOME TOKYO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-11-20 |