MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-03-12 for OLYMPUS EVIS EXERA PEDIATRIC COLONOVIDEOSCOPE PCF-160AL NA manufactured by Olympus Medical Systems Corporation.
[1480269]
The user facility reported to have experienced a complete loss of image during a colonoscopy. The procedure was reportedly stopped, as the users did not have a spare colonoscopy available at the time, however, the procedure was completed later in the same day. There were no complications experienced and the patient was said to be fine following the completion of the procedures.
Patient Sequence No: 1, Text Type: D, B5
[8444480]
The device referenced in this report was returned to olympus for evaluation. The evaluation did not duplicate a complete loss of image. However, the evaluation found that the image was tilted and would flicker, and was intermittent when the bending section was angulated. The device failed the electrical insulation testing, and a crack was found in the distal end cover. One of the light guide lenses was also cracked. The cause of the image loss was likely the result of a damaged charge coupled display (ccd) unit caused by physical damage to the colonovideoscope. The device was serviced and returned to the user facility. The pcf-160al advises users to inspect the device prior to each use, and to not use the device if any anomalies are detected. This report is being submitted as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2010-00043 |
| MDR Report Key | 1634213 |
| Report Source | 05,06 |
| Date Received | 2010-03-12 |
| Date of Report | 2010-02-16 |
| Date of Event | 2010-02-01 |
| Date Mfgr Received | 2010-02-16 |
| Date Added to Maude | 2010-09-10 |
| 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 | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 192-8507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS EVIS EXERA PEDIATRIC COLONOVIDEOSCOPE |
| Generic Name | COLONSCOPE |
| Product Code | FTJ |
| Date Received | 2010-03-12 |
| Returned To Mfg | 2010-02-16 |
| Model Number | PCF-160AL |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-03-12 |