MAUDE Adverse Event Report: KeyMed (Medical and Industrial Equipment) Ltd. FLUSHING PUMP OFP-2 (US); Olympus Flushing Pump

Model Number	K10001141
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they had to run the pump using the foot pedal to adjust the flow rate during inspection for use involving an olympus flushing pump.There was no patient involvement.
Additional Manufacturer Narrative
The final investigation has been completed.As the device was not returned to olympus for inspection, the failure reported by the customer could not be confirmed.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor the field performance of this device and evaluate any additional information received through post market surveillance activities.

• Brand Name: FLUSHING PUMP OFP-2 (US)
• Common Device Name: Olympus Flushing Pump
• 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: 50842366
• Report Number: 9611174-2026-00210
• Device Sequence Number: 9949788
• Product Code: FEQ
• UDI-Device Identifier: 15019778004716
• UDI-Public: 15019778004716
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: K10001141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/21/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown