The customer suspected device was returned for investigation.The olympus service center confirmed the reported event during inspection and testing.Upon evaluation of the returned device the following defects were found, nozzle had foreign objects, due to wear of angle wire, bending angle in up direction did not meet the standard value, due to wear of angle wire, the play of up/down knob out of the standard value, adhesive on angle rubber chipped, adhesive on angle rubber had white-clouded area, switch 2 h scratched, image guide protector scratched, protector of universal cord on control section side scratched, connecting tube scratched, and connecting tube wrinkled.The faulty parts were replaced, and the device was returned to the user facility.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
|
A user facility submitted a repair request to the olympus service center, for a gastrointestinal videoscope having drainage issue.It was reported that the intended procedure was completed using the same device.Upon inspection and testing of the customer returned device, foreign material was found clogged in the scope air/water nozzle due to insufficient cleaning.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.There was no report of patient harm or user injury associated with this event.
|
Customer additionally reported that the device was cleaned, disinfected, and sterilized before it was returned to olympus.It was not known when the foreign material adhered to the endoscope.There was no delay in the start of precleaning.No abnormalities in the accessories used in reprocessing.The air/water nozzle was flushed with detergent.
|