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

Model Number	EPK-3000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is classified as import for export, therefore 510k is not applicable.Model epk-3000us is available in the usa with 510k number k172156.Evaluation summary: it was caused due to dust in the unit.In addition, we confirmed that lamp malfunction and the lamp power supply unit malfunction.However, these are not related to the alleged complaint.This report is being filed as part of the pentax backlog management plan.
Event or Problem Description
When the lamp was lit on (b)(6) 2021, a lamp lighting failure (error 03-1000) occurred.When i pressed the lamp button again, it turned on, so there was no problem with the inspection.There are 4 occurrence histories in the error log during march.I don't know if it's the direct cause, but there is a whitish deposit on the right terminal of the lamp mounting part and its surroundings.(see attached image) since it occurred before use, there is no health hazard to patients and healthcare professionals.Software version: 00b8c-1.3000, system life: 3671 hours 16 minutes 13 seconds, cumulative lighting time: 147 hours 20 minutes 31 seconds, number of lights: 2198 times, initialization execution count: 9 times.Lamp power supply board dust countermeasures: measures have been taken.Door change: measures taken.

• Brand Name: PENTAX
• Common Device Name: VIDEO PROCESSOR (INTERNATIONAL)
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 19600 12; JA 1960012
• MDR Report Key: 12272345
• Report Number: 9610877-2021-10329
• Device Sequence Number: 3532273
• 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): 08/04/2021

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: 04/05/2021
• Initial Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1