Model Number OER-PRO |
Device Problem
Crack (1135)
|
Patient Problem
No Patient Involvement (2645)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Olympus field service engineer (fse) confirmed a cracked push plate was found while performing preventive maintenance.The device was repaired on site and verified that it was working as specified.The equipment passed the electrical and safety tests.If additional information is obtained a supplemental mdr will be filed.
|
|
Event Description
|
A technician reported that an endoscope reprocessor required repairs on a cracked lid found during preventive maintenance.No patient injury was reported.No additional information has been obtained.
|
|
Manufacturer Narrative
|
The investigation has been completed.A device history record (dhr) review was performed and found no non-conformances that would cause the reported malfunction.All records indicate that the device was manufactured in accordance with all applicable procedures.The instructions for use (ifu) states: ¿when closing the lid, be careful not to get the connecting tube caught between the reprocessing basin and lid and make sure the endoscopes and the washing case are not touching the lid.Close the lid after ensuring that the cover of the washing case is closed.¿ the root cause was not determined.Probable causes are that the lid may have been contacted by a scope when it was closed and/or something hard hit the lid causing the damage.
|
|
Search Alerts/Recalls
|