MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. OFP FLUSHING PUMP; OLYMPUS FLUSHING PUMP

Model Number	7501349
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.Technical assistance center (tac) provided education via phone call conference with the customer.Tac educated the customer that a lose olympus flushing pump (ofp) water bottle cap will not produce an airtight seal and will produce dribbling from the distal end of the scope.The customer stated the staff retightened the seal and the dribbling of water from the distal tip of the scope stopped immediately.Tac informed the customer that the pump head item #7502419 should be changed every 12 months.Tac emailed the customer the following statement: ¿the item listed below should be changed every 12 months.7502419 (pump head assembly spare).This item can be ordered through our customer care dept.By calling 800-848-9024, option 2.¿ the issue was resolved.No further tac assistance is needed.
Event or Problem Description
It was reported the olympus flushing pump had dribbling from the distal end during a diagnostic colonoscopy.The procedure was completed with the same device.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.Updated fields: h2, h3, h6, h11.The device was not returned to olympus for inspection.However, technical assistance center (tac) provided remote troubleshooting and loose water bottle cap will not produce an airtight seal and will produce dribbling from the distal end of the scope and the reported failure was confirmed.In addition, the following reportable malfunctions were identified during the device evaluation: loose water bottle cap.Based on the results of the investigation, due to retightened the seal and the dribbling of water from the distal tip of the scope stopped immediately.A definitive root cause could not be identified.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from the customer.

• Brand Name: OFP FLUSHING PUMP
• 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 ; 5082077661
• MDR Report Key: 24203829
• Report Number: 9611174-2026-00030
• Device Sequence Number: 9654019
• Product Code: FEQ
• UDI-Device Identifier: 15019778003528
• UDI-Public: 15019778003528
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 06/02/2026

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: 7501349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2008
• 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