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

Model Number	K10001141
Medical Device Problem Codes	Improper Flow or Infusion (2954); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported an issue with the front keypad and was unable to adjust the flow during an unspecified procedure involving an olympus flushing pump.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was returned to olympus for inspection, and the reported failure was confirmed.Based on the results of the investigation, the cause of the reported malfunction front keypad issue and unable to adjust the flow was traced to be a component failure like electrical problem.Date of event is unknown.Additional information will be provided once available.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 (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: 50704861
• Report Number: 9611174-2026-00201
• Device Sequence Number: 10696359
• Product Code: FEQ
• UDI-Device Identifier: 15019778004716
• UDI-Public: 15019778004716
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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?: Yes
• Date Returned to Manufacturer: 08/18/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2014
• 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