PENTAX
Report
- Report Number
- 9610877-2022-00144
- Event Type
- Malfunction
- Date Received
- January 17, 2022
- Date of Event
- December 27, 2021
- Report Date
- March 11, 2022
- Manufacturer
- HOYA CORPORATION PENTAX TOKYO OFFICE
- Product Code
- FDF
- UDI-DI
- 04961333237869
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EC38-I10CL-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K190805.
EVALUATION SUMMARY: THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EC38-I10CL-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K190805. 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. IN ADDITION, WE CONFIRMED THAT THE R/L PULLEY WIRE WORN OUT, AND THE U/D PULLEY WIRE RUPTURE; HOWEVER, THEY ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR. CORRECTION INFORMATION: FOLLOW UP #1, CODING CHANGED BASED ON THE INVESTIGATION RESULT. ADDITIONAL INFORMATION: DEVICE MANUFACTURE DATE.
DISTRIBUTOR: FOGGING AND SPOTS ON CAMERA IMAGE. THIS EVENT OCCURRED AT THE TIME OF DURING INSPECTION. THERE WAS NO REPORT OF PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 821267 | PENTAX | VIDEO COLONO SCOPE | FDF | HOYA CORPORATION PENTAX TOKYO OFFICE | EC38-I10CL | 04961333237869 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |