Model Number CYF-VHA |
Device Problem
Device Reprocessing Problem (1091)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
During a demonstration, the olympus field service engineer discovered cyf and urf type endoscopes were cleaned with a broken endoscope washer-disinfector machine as a broken pull rod for the upper basket the machine was observed.The customer mainly cleans the endoscopes without internal radio-frequency identification (rfid) and the machine did not report any error for the broken pull rod.Thus, channels of the endoscope may not have been cleaned properly without the machine indicating this.No death, injury or infection has been reported.This is for report 1 of 2.
|
|
Manufacturer Narrative
|
The investigation is ongoing; therefore, the root cause of the reported issue/malfunction cannot be determined at this time.However, if additional information becomes available a follow up medical device report will be supplemented accordingly.
|
|
Manufacturer Narrative
|
This supplemental report was submitted to provide additional information from the legal manufacturer.It was further reported that the washer machine has been repaired.Also, the urf and cyf scopes been cleaned after machine was repaired.Customer has not reported patient infection or cross-contamination.The investigation was completed by the legal manufacturer and the cause of the channels of the endoscope may not have been cleaned properly without the machine indicating an error cannot be conclusively determined.However, based on the information, the cause is likely due to the broken parts/component of the machine.In addition, we have confirmed that this phenomenon does not occur due to product or manufacturing, and that there is no problem with safety.(there is no multiple occurrence.) olympus will continue to monitor complaints for this device.
|
|
Search Alerts/Recalls
|
|