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 2007-10-25 for OLYMPUS CF-Q160L manufactured by Olympus Medical Systems Corporation.
[16027310]
The user facility reported that during multiple colonoscopies, there was insufficient air and suction flow. The procedures were completed with a different, but similar device. The facility reported, there were no patient injuries associated with these phenomena, but some of the patients were given additional anesthesia because the procedures took longer.
Patient Sequence No: 1, Text Type: D, B5
[16121680]
The device referenced in this report was returned to olympus for evaluation. The investigation did not duplicate the user's report of insufficient air and suction flow. The air/water flow and capacity were tested and found to be within specifications. The biopsy and suction channel were also inspected and no obstructions were found. The right/left release knee knob was noted to move unexpectedly when right/left angulation control knob was turned due to a damaged locking mechanism. However, this finding would not likely cause or contribute to the reported event. The cause of the user's experience cannot be determined. This report is being filed in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2007-00167 |
| MDR Report Key | 932380 |
| Report Source | 00,05,06 |
| Date Received | 2007-10-25 |
| Date of Report | 2007-09-27 |
| Date Added to Maude | 2007-12-17 |
| 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 | EVIS EXERA COLONOVIDEOSCOPE |
| Product Code | FTJ |
| Date Received | 2007-10-25 |
| 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 | 931264 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | SHINJUKU-KU, 1-CHOME TOKYO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-25 |