MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OLYMPUS AFU-100 (100...240 V~); ENDOSCOPIC FLUSHING PUMP

Model Number	WB950167
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the error message reported by the user was confirmed.The unit was failing to activate the pump motor when the footswitch was pressured due to a faulty sa controller board.Additionally, the unit operated with a noise due to a worn out gear box unit.The aforementioned components were replaced, successfully tested, and the device was returned to the customer on 15jan2021.If additional information becomes available following device evaluation, a supplemental report will be filed.
Event or Problem Description
As reported, during procedure preparation, the olympus afu-100 displayed error message e24.There was no patient harm or consequence as a result of this event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.A review of the device history record (dhr) was conducted during this investigation.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.Based on the results of the investigation, the reported event was caused by deterioration of the device.Error 24 occurs when the pump head is mechanically blocked.An internal defect of the control board can also trigger this error.In this case, the controller board was the cause of the error message.Olympus will continue to monitor the field performance of this device.

• Brand Name: OLYMPUS AFU-100 (100...240 V~)
• Common Device Name: ENDOSCOPIC FLUSHING PUMP
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 11204861
• Report Number: 9610773-2021-00050
• Device Sequence Number: 14181896
• Product Code: GEI
• UDI-Device Identifier: 04042768501678
• UDI-Public: 04042768501678
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K073207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WB950167
• Device Catalogue Number: WB950167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1