FDA Adverse Event Malfunction Summary report: N

PENTAX

MDR report key: 21099097 · Received January 8, 2025

Report

Report Number: 9610877-2025-50074
Event Type: Malfunction
Date Received: January 8, 2025
Date of Event: January 2, 2025
Report Date: January 8, 2025
Manufacturer: HOYA CORPORATION PENTAX TOKYO OFFICE
Product Code: EOQ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

G4: THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EB15-J10 IS AVAILABLE IN THE USA WITH A 510K NUMBER K200678. 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 OPERATION CHANNEL (PRIMARY) STUCK ACCESSORY/OBJECT. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE INADEQUATE/INSUFFICIENT REPROCESSING AT THE FACILITY ON THE OPERATION CHANNEL (PRIMARY). 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
1011555	PENTAX	VIDEO BRONCHOSCOPE	EOQ	HOYA CORPORATION PENTAX TOKYO OFFICE	EB11-J10

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown