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 2007-12-28 for OLYMPUS CF-H180AL manufactured by Olympus Medical Systems Corporation.
[753757]
The user facility reported that during a diagnostic colonoscopy, they experienced a total loss of video image. A nurse at the facility reported that at the start of the procedure, the video image functioned appropriately, but gradually changed in the middle of the procedure. The video image reportedly became grainy, followed by horizontal lines on the video monitor and computer screen, and finally the video image was lost. The procedure was completed with a different set of equipment in another procedure room. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[8035072]
The device referenced in this report was returned to olympus for investigation. The investigation confirmed that the image flickered and blacked out when manipulating the bending section area. The shape of the bending section was observed to be irregular when angulated in the up direction due to multiple broken rings on the interior of the device. The charge coupled device (ccd) wires were found to be cut due to the broken angle wire rings, which most likely caused or contributed to the user's experience. The broken rings were determined to be due to physical damage to the endoscope. This report is being filed as an mdr in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2007-00210 |
| MDR Report Key | 970624 |
| Report Source | 00,05,06 |
| Date Received | 2007-12-28 |
| Date of Report | 2007-12-03 |
| Date of Event | 2007-11-28 |
| Date Added to Maude | 2008-04-09 |
| 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 | 2007-12-28 |
| Model Number | CF-H180AL |
| 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 | 973579 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | SHINJUKU-KU, 1-CHOME TOKYO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-28 |