FLUSHING PUMP OFP-2 (JP)
Report
- Report Number
- 9611174-2024-01309
- Event Type
- Malfunction
- Date Received
- July 9, 2024
- Report Date
- September 10, 2024
- 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
- OTHER
- Health Professional
- N
Narratives
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. UPDATED FIELDS: B5, D8, H2, H3, H4, H6, H11 A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: FAILURE OF AIR SWITCH U. THE MOST PROBABLE ROOT CAUSE TRACED TO COMPONENT FAILURE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
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.
IT WAS REPORTED THAT THE SUBJECT DEVICE'S FOOTSWITCH CONNECTING SECTION WAS DAMAGED. THE ISSUE WAS REPORTED DURING DIAGNOSTIC COLONOSCOPY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
IT WAS REPORTED THAT THE SUBJECT DEVICE'S FOOTSWITCH CONNECTING SECTION WAS DAMAGED. THERE WERE NO REPORTS OF PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1499174 | 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 |