FDA Adverse Event
Malfunction
Summary report: N
PENTAX
MDR report key: 13023724
·
Received December 17, 2021
Report
- Report Number
- 9610877-2021-50855
- Event Type
- Malfunction
- Date Received
- December 17, 2021
- Date of Event
- December 8, 2021
- Report Date
- December 17, 2021
- Manufacturer
- HOYA CORPORATION PENTAX TOKYO OFFICE
- Product Code
- EOB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL FNL-10RP3 IS AVAILABLE IN THE USA WITH A 510K NUMBER K951196. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE CFB IMAGE FAILURE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE CFB. BASED ON THE TECHNICAL REPORT AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.
Description of Event or Problem · 0
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE (BROKEN).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1930297 | PENTAX | FIBER NASO PHARYNGO LARYNGOSCOPE | EOB | HOYA CORPORATION PENTAX TOKYO OFFICE | FNL-10RBS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |