FDA Adverse Event Malfunction Summary report: N

PENTAX

MDR report key: 21121352 · Received January 10, 2025

Report

Report Number: 9610877-2025-50161
Event Type: Malfunction
Date Received: January 10, 2025
Date of Event: December 19, 2024
Report Date: January 10, 2025
Manufacturer: HOYA CORPORATION PENTAX TOKYO OFFICE
Product Code: FDS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

G4: THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EG29-I20C-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K231249. D4 UDI: "NOT DISTRIBUTED IN USA", BECAUSE PRODUCTS ARE NOT DISTRIBUTED IN USA PRODUCTS, BUT SIMILAR DEVICE PRODUCT ARE LISTED IN USA. THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE IMAGE MISSING. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE CMOS MODULE. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE CCD DRIVE PCB FLUID DAMAGE, THE ELECTRICAL PIN CONNECTOR FLUID DAMAGE, THE LG CONNECTOR FLUID DAMAGE, THE OBJECTIVE LENS CLOUDY (NOT CLEAR VIEW), THE INSERTION FLEXIBLE TUBE COMPRESSED (SHORT IN LENGTH), THE OBJECTIVE LENS SCRATCHED, THE R/L PULLEY WIRE RUPTURE, AND THE CMOS MODULE WITH DRIVE PCB OBJECTIVE LENS CRACKED; HOWEVER, THESE DEFECTS ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT ""HR-RPT-0586(IMAGE FAILURE)"" 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 (BLACKOUT).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1224920	PENTAX	VIDEO GASTROSCOPE - I20C STANDARD	FDS	HOYA CORPORATION PENTAX TOKYO OFFICE	EG29-I20C

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown