MH-498 (E) CONNECTING ARM OF SH-1
Report
- Report Number
- 3002808148-2024-06351
- Event Type
- Malfunction
- Date Received
- July 12, 2024
- Report Date
- July 29, 2024
- Manufacturer
- SHIRAKAWA OLYMPUS CO., LTD.
- Product Code
- OCV
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. CORRECTED FIELDS: B5, D4, D8. ADDITIONAL INFORMATION ADDED TO FIELD H3, H6. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S COMPLAINT OF COATING-LIKE MATERIAL PEELING OFF FROM VARIOUS PARTS WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITE ROOT CAUSE THAT LED TO THE MALFUNCTION COULD NOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
IT WAS REPORTED, THE CONNECTING ARM HAD COATING LIKE MATERIAL WAS PEELING OFF IN VARIOUS PLACES. IT IS UNKNOWN WHEN THE ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.
THE ISSUE OCCURRED DURING INSPECTION FOR USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1269603 | MH-498 (E) CONNECTING ARM OF SH-1 | CONNECTING ARM | OCV | SHIRAKAWA OLYMPUS CO., LTD. | MH-498 | 52R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |