FDA Adverse Event
Malfunction
Summary report: N
PENTAX
MDR report key: 13468796
·
Received February 7, 2022
Report
- Report Number
- 9610877-2022-50516
- Event Type
- Malfunction
- Date Received
- February 7, 2022
- Date of Event
- January 11, 2022
- Report Date
- February 7, 2022
- Manufacturer
- HOYA CORPORATION PENTAX TOKYO OFFICE
- Product Code
- FDF
- UDI-DI
- 04961333234066
- PMA / PMN Number
- K180285
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- 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 EC34-I10TL-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K180285. WE CHECKED THE RETURNED UNIT AND CONFIRMED THE CCD MODULE AS DEFECTIVE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE CCD MODULE. 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. VIDEO IMAGE FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 594258 | PENTAX | VIDEO COLONOSCOPE | FDF | HOYA CORPORATION PENTAX TOKYO OFFICE | EC34-I10TL | 04961333234066 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |