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	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer returned the olympus flushing pump with no customer allegation.During the initial evaluation of the returned device, a brown and black substance was observed in the water bottle.There was no patient involvement.
Additional Manufacturer Narrative
The date of event is unknown.Additional information will be provided if available.Based on the final investigation of the device the a brown and black substance was found in the water bottle during the initial evaluation was confirmed.Based on the results of the investigation a definitive root cause could not be identified.Should any additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor the field performance of 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: 50804088
• Report Number: 9611174-2026-00205
• Device Sequence Number: 10548992
• Product Code: FEQ
• UDI-Device Identifier: 15019778004716
• UDI-Public: 15019778004716
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: Other
• Device Model Number: K10001141
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/26/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/17/2026
• 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