MAUDE Adverse Event Report: KeyMed (Medical and Industrial Equipment) Ltd. FLUSHING PUMP OFP-2 (ROW); Pump, Air, Non-Manual, For Endoscope

Model Number	K10001145
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.Updated fields: d8, h2, h3, h6 and h11.The device was returned to olympus for inspection and the reported failure was confirmed.A root cause could not be identified.Based on the results of the investigation, the most probable cause of the water output not being smooth was component failure of the pump head.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: FLUSHING PUMP OFP-2 (ROW)
• Common Device Name: Pump, Air, Non-Manual, For Endoscope
• Manufacturer (Section D): KeyMed (Medical and Industrial Equipment) Ltd.; keymed house, stock road; southend on sea, essex SS25Q H; UK SS25QH
• Manufacturer (Section G): KeyMed (Medical and Industrial Equipment) Ltd.; keymed house, stock road; southend on sea, essex SS25Q H; UK SS25QH
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; +1(508)207-7661
• MDR Report Key: 50286958
• Report Number: 9611174-2026-00185
• Device Sequence Number: 21508331
• Product Code: FEQ
• UDI-Device Identifier: 15019778003238
• UDI-Public: 15019778003238
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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: K10001145
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/22/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/22/2026
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 08/17/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown