MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-10-12 for OLYMPUS EVIS EXERA COLONOVIDEOSCOPE CF-Q160AL manufactured by Olympus Medical Systems Corporation.
[1701302]
The user facility reported that the subject colonovideoscope was used in a colonoscopy in which the pt reportedly sustained a perforation in the colon. The pt was transported to another facility for surgical correction. The pt is reportedly doing fine following the procedure.
Patient Sequence No: 1, Text Type: D, B5
[8688084]
Olympus followed up with the user facility to obtain additional information regarding the reported event, and was informed that the device was being used in a screening colonoscopy. The perforation was observed at an unspecified area of the colon shortly after starting the procedure, and upon discovery, the colonoscope was immediately removed from the pt. The procedure was not completed. The user facility also reported to have performed a visual and mechanical inspection of the device and did not observe any indications of damage that could create poor clinical outcomes. The device was returned to olympus for evaluation, the evaluation noted the presence of small dents and scratches on the distal end cover, insertion tube, objective lens, light guide tube, and minor cracks in the glue bonds on the bending section cover. The objective lens had small chips around the edge. The nicks and scratches were carefully inspected, and determined not to be sharp. The device was serviced. The exact cause of the pt's experience could not be conclusively determined. This report is being submitted as a medical device report in an abundance of caution. This is report two of two, please see also mfr#8010047-2010-00210 for a related report.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 8010047-2010-00211 |
MDR Report Key | 1873568 |
Report Source | 05,06 |
Date Received | 2010-10-12 |
Date of Report | 2010-09-27 |
Date of Event | 2010-09-27 |
Date Mfgr Received | 2010-09-27 |
Date Added to Maude | 2010-10-26 |
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 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
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 CORP |
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 | COLONOSCOPE |
Product Code | FTJ |
Date Received | 2010-10-12 |
Returned To Mfg | 2010-09-29 |
Model Number | CF-Q160AL |
Lot Number | NA |
Device Availability | Y |
Device Age | DA |
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, TOKYO 192-8507 JA 192-8507 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2010-10-12 |