MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-09-13 for OLYMPUS EVIS EXERA COLONOVIDEOSCOPE CF-Q160L manufactured by Olympus Medical System Corporation.
[1474238]
The user facility reported that during a diagnostics colonoscopy procedure, the physician reportedly experienced difficulty attempting to remove the colonoscope. The physician attempted to turn the device, and perforated the pt's bowel. The pt was immediately taken to surgery, laparoscopy was performed and the perforation was corrected. The pt was said to have been discharged and is reported to be doing well.
Patient Sequence No: 1, Text Type: D, B5
[8758850]
Olympus followed up with the user facility to obtain additional info regarding the report. The facility has declined to return the device for eval, however an olympus endoscope svc specialist was allowed to examine the device on-site. The endoscope was noted to have excessive play in the angulation controls, the insertion tube was worn, and the device appeared to have buckling along the length of the insertion tube. The insertion tube was reported to appear "very floppy. " review of the device instrument history indicates that the colonoscope was last serviced by olympus on 07/10/2009, when the unit had received a complete refurbishment. The cause of the reported phenomenon cannot be conclusively determined. This report is being submitted as an mdr in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2010-00173 |
| MDR Report Key | 1837862 |
| Report Source | 06 |
| Date Received | 2010-09-13 |
| Date of Report | 2010-08-13 |
| Date Mfgr Received | 2010-08-13 |
| Date Added to Maude | 2010-12-03 |
| 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 SYSTEM CORPORATION |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO 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 COLONOVIDEOSCOPE |
| Generic Name | COLONSCOPE |
| Product Code | FTJ |
| Date Received | 2010-09-13 |
| Returned To Mfg | 2010-08-18 |
| Model Number | CF-Q160L |
| Lot Number | NA |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEM CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-13 |