MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO PROCESSOR (INTERNATIONAL)

Model Number	EPK-3000
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary : it was caused due to the malfunction on the xenon lamp.This device is classified as import for export, therefore 510k is not applicable.Model epk-3000-us is available in the usa with a 510k number k172156.This report is being filed as part of the pentax backlog management plan.
Event or Problem Description
It was informed that the amount of light was darker than the facility and could not be used for medical examinations.The amount of light from the light guide insertion part is dark enough to be seen, and it seems that the diaphragm is not working.Check the log in-house.No error log is output.The phenomenon is not reproduced.This event occurred at the time of before use.There was no report of patient harm.

• Brand Name: PENTAX
• Common Device Name: VIDEO PROCESSOR (INTERNATIONAL)
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12186981
• Report Number: 9610877-2021-10157
• Device Sequence Number: 3509142
• Product Code: PEA
• UDI-Device Identifier: 04961333225262
• UDI-Public: 04961333225262
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EPK-3000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1