RHINO-LARYNGO VIDEOSCOPE
Report
- Report Number
- 3002808148-2022-02317
- Event Type
- Malfunction
- Date Received
- September 23, 2022
- Report Date
- October 27, 2022
- Manufacturer
- SHIRAKAWA OLYMPUS CO., LTD.
- Product Code
- EOB
- UDI-DI
- 04953170411366
- PMA / PMN Number
- K061313
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THE SUGGESTED PHENOMENON WAS PRESUMED TO HAVE BEEN DUE TO STRESS OR USER¿S HANDLING. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
THE DEVICE IS RETURNED AND AN EVALUATION COMPLETED FOR IT. UPON INSPECTION OF THE DEVICE, IT WAS OBSERVED THAT THE IMAGE GUIDE (IG) HOB WAS DETACHED FROM THE DISTAL END. EVALUATION IS ONGOING. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED WHEN ANY RELEVANT NEW INFORMATION IS AVAILABLE.
CUSTOMER RETURNED THE DEVICE FOR EVALUATION AND REPAIR OF A TORN SERPENTINE TUBE. THERE IS NO HARM TO ANY PATIENT OR PERSONS. UPON EVALUATION OF THE RETURNED DEVICE IT WAS OBSERVED THAT THE IMAGE GUIDE (IG) HOB WAS DETACHED FROM THE DISTAL END. THIS MEDWATCH IS BEING SUBMITTED FOR THE REPORTABLE ISSUE OF THE DETACHED IG HOB AS OBSERVED DURING DEVICE EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2828710 | RHINO-LARYNGO VIDEOSCOPE | RHINO-LARYNGO VIDEOSCOPE | EOB | SHIRAKAWA OLYMPUS CO., LTD. | ENF-V3 | 04953170411366 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |