MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-03-28 for OLYMPUS CF-Q160AL manufactured by Olympus Medical Systems Corporation.
[17017171]
The user facility reported that during a colonoscopy, a complete loss of image was experienced, and the image could not be recovered. The procedure was reportedly completed with a different, but similar device. There was no patient injury and no further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[17240724]
The device referenced in this report was returned to olympus for investigation. The investigation confirmed the user's report of image difficulty. The image was found to contain static and flicker intermittently after the device was tested for several hours. There was evidence of fluid found inside the endoscope connector, and a crack noted on the light guide lens. A large dent was observed on the distal end cover. Additionally, the variable stiffness and angulation control knobs were determined to not function properly due to stretched coil and angle wires, likely due to extended use. The bending cover was disassembled and broken/frayed wires were found on the bending section mesh, also due to extensive usage. Following aeration, the unit was retested and the image was found to be within standard. As the unit passed leak testing, user handling cannot be ruled out as the source of the fluid invasion. This report is being filed as an mdr in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2008-00055 |
| MDR Report Key | 1021931 |
| Report Source | 06 |
| Date Received | 2008-03-28 |
| Date of Report | 2008-02-28 |
| Date Added to Maude | 2008-07-02 |
| 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 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 CLONOVIDEOSCOPE |
| Product Code | FTJ |
| Date Received | 2008-03-28 |
| Model Number | CF-Q160AL |
| Lot Number | NA |
| 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 | 1024858 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | SHINJUKU-KU, 1-CHOME TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-28 |