FDA Adverse Event Malfunction Summary report: N

PENTAX

MDR report key: 12472571 · Received September 15, 2021

Report

Report Number: 9610877-2021-00953
Event Type: Malfunction
Date Received: September 15, 2021
Date of Event: August 19, 2021
Report Date: December 17, 2021
Manufacturer: HOYA CORPORATION PENTAX TOKYO OFFICE
Product Code: FDF
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SF
Reporter Occupation: OTHER
Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

EVALUATION SUMMARY: THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EG29-I10C-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 CCD DRIVER PCB MALFUNCTION, THE SEGMENT LOOSENED, AND THE LG CABLE CONNECTOR CORRODED; 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: G6: FOLLOW UP #1. H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT.

Additional Manufacturer Narrative · 1

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 EG29-I10C IS AVAILABLE IN THE USA WITH A 510K NUMBER K190805.

Description of Event or Problem · 1

THERE IS NO 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
1370566	PENTAX	VIDEO COLONOCOPE - I10 STANDARD	FDF	HOYA CORPORATION PENTAX TOKYO OFFICE	EC38-I10L

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown