MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-04-04 for OLYMPUS CF-Q160AL manufactured by Olympus Medical Systems Corporation.
[812181]
The user facility reported that during a diagnostic colonoscopy, horizontal lines were observed on the screen while in use. The image reportedly was completely lost, and in turn, failed to retrieve the image. The procedure was completed with a similar device (serial number unknown) with no allegation of patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[7991341]
The device referenced in this report was returned to olympus for investigation. The investigation found the image intermittently flickering and smearing with rainbow spots and horizontal lines when the electrical connector was manipulated. A small leak was found at the air/water nozzle. There were fluid stains and residue found on the exterior part of the electrical connector mouthpiece and contact pins, which most likely was the cause of the image problems. There was also evidence of a previous fluid invasion inside the endoscope connector. There were severe buckles, scrapes and peelings/cracks on the insertion tube and light guide tube. Repeated fluid invasions and/or physical damage likely contributed to the reported event. This report is being filed as an mdr, in an abundance of caution. Additional comments: the device instruction manual advises users how to perform leak testing, and further advises users not to use the device if a leak is detected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2008-00059 |
| MDR Report Key | 1025846 |
| Report Source | 05,06 |
| Date Received | 2008-04-04 |
| Date of Report | 2008-03-05 |
| Date of Event | 2008-03-05 |
| Date Added to Maude | 2008-08-11 |
| 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 | COLONOSCOPE |
| Product Code | FTJ |
| Date Received | 2008-04-04 |
| 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 | 1026799 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | SHINJUKU-KU, 1-CHOME TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-04 |