OLYMPUS EVIS EXERA COLONOVIDEOSCOPE CF-Q160AL

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number8010047-2010-00211
MDR Report Key1873568
Report Source05,06
Date Received2010-10-12
Date of Report2010-09-27
Date of Event2010-09-27
Date Mfgr Received2010-09-27
Date Added to Maude2010-10-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactLAURA STORMS-TYLER
Manufacturer Street2400 RINGWOOD AVE
Manufacturer CitySAN JOSE CA 95131
Manufacturer CountryUS
Manufacturer Postal95131
Manufacturer Phone4848965688
Manufacturer G1OLYMPUS MEDICAL SYSTEM CORP
Manufacturer Street2951 ISHIKAWA-CHO
Manufacturer CityHACHIOJI-SHI, TOKYO 192-8507
Manufacturer CountryJA
Manufacturer Postal Code192-8507
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOLYMPUS EVIS EXERA COLONOVIDEOSCOPE
Generic NameCOLONOSCOPE
Product CodeFTJ
Date Received2010-10-12
Returned To Mfg2010-09-29
Model NumberCF-Q160AL
Lot NumberNA
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS MEDICAL SYSTEMS CORPORATION
Manufacturer Address2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507


Patients

Patient NumberTreatmentOutcomeDate
10 2010-10-12

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