FLUSHING PUMP OFP-2 (US)
Report
- Report Number
- 9611174-2026-00029
- Event Type
- Malfunction
- Date Received
- January 28, 2026
- Date of Event
- January 5, 2026
- Report Date
- April 29, 2026
- Manufacturer
- KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.
- Product Code
- FEQ
- UDI-DI
- 15019778004716
- PMA / PMN Number
- K100899
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION AND A CORRECTION. UPDATED FIELDS: B5, D9, H2, H3, H4, H6 AND H11. CORRECTED FIELDS: H8. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, THE CAUSE REPORTED MALFUNCTION NONFUNCTIONAL PANEL SWITCH AND NON-ADJUSTABLE WATER FLOW WAS A DEFECTED BUTTON AND ALSO A COMPONENT FAILURE LIKE DEGRADATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
IT WAS REPORTED THE PANEL SWITCH OF THE FLUSHING PUMP WAS NOT WORKING PROPERLY, CAUSING THE INABILITY TO ADJUST WATER PRESSURE. THERE WERE NO REPORTS OF PATIENT HARM.
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 350790 | FLUSHING PUMP OFP-2 (US) | OLYMPUS FLUSHING PUMP | FEQ | KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. | K10001141 | 15019778004716 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |