FDA Adverse Event Malfunction Summary report: N

PENTAX

MDR report key: 23287447 · Received October 15, 2025

Report

Report Number: 9610877-2025-53632
Event Type: Malfunction
Date Received: October 15, 2025
Date of Event: October 7, 2025
Report Date: October 14, 2025
Manufacturer: HOYA CORPORATION PENTAX TOKYO OFFICE
Product Code: GCL
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

G4: THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EE-1580K IS AVAILABLE IN THE USA WITH A 510K NUMBER K961564. 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 SUCTION CHANNEL BLOCKED. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE INADEQUATE/INSUFFICIENT REPROCESSING AT THE FACILITY ON THE SUCTION CHANNEL. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE LCB (LIGHT CARRYING BUNDLE) BROKEN, AND THE AIR/WATER NOZZLE DEFORMED; HOWEVER, THESE DEFECTS ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. THIS DEFECT OCCURRED NOT DURING PROCEDURE. BASED ON THE TECHNICAL REPORT ""HR-RPT-0588(CHANNEL)"" AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.

Description of Event or Problem · 0

THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. OPERATION/SUCTION CHANNEL CLOGGED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2792055	PENTAX	VIDEO ESOPHAGOSCOPE	GCL	HOYA CORPORATION PENTAX TOKYO OFFICE	EE17-J10

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown