FLUSHING PUMP OFP-2 (JP)
Report
- Report Number
- 9611174-2024-01473
- Event Type
- Malfunction
- Date Received
- September 3, 2024
- Date of Event
- August 23, 2024
- Report Date
- January 6, 2025
- Manufacturer
- KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.
- Product Code
- FEQ
- PMA / PMN Number
- K100899
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
E2/E3: NO INFORMATION AVAILABLE FOR THE OCCUPATION OF THE INITIAL REPORTER OR WHETHER THEY ARE A HEALTHCARE PROFESSIONAL. 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 LEGAL MANUFACTURER'S FINAL INVESTIGATION.THE DEVICE WAS RETURNED TO THE OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: COMPONENT FAILURE OF THE FLUSHING PUMP. 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 THAT THE SUBJECT DEVICE HAD A DEFECTIVE WATER SUPPLY. THERE WERE NO REPORTS OF PATIENT HARM.
ADDITIONAL INFORMATION WAS RECEIVED FROM CUSTOMER: THE EVENT OCCURRED ON INSPECTION PRIOR TO PROCEDURE. THE PROCEDURE WAS AN THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION AND WAS COMPLETED WITH THE SAME EQUIPMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 699959 | FLUSHING PUMP OFP-2 (JP) | OLYMPUS FLUSHING PUMP | FEQ | KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. | K10001142 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |