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

Model Number	EPK-3000
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Import for export.(b)(4).
Event or Problem Description
Pentax medical was made aware of a complaint on (b)(6) 2020 stating "on (b)(6) 2020, when the lamp was turned on after startup, a strange noise was heard, a spark was witnessed, and the lamp did not turn on.(check log 03-4000 and 03-1000) no damage due to abnormal noise and sparks." involving pentax medical video processor, model epk-3000, serial number (b)(4).No serious injury or death of a patient or user was reported.During pentax medical inspection, the device was replaced with a substitute and confirmed "aux lamp on.Check main lamp".Software version: (b)(4) system life: 3256 hours 17 minutes 26 seconds total lighting time: 23 hours 9 minutes 55 seconds number of lighting: 1340 times number of initialization executions: 4 times measures against dust on lamp power board: not supported.Door change: already supported the igniter was found to be the cause because the phenomenon was improved by replacing the igniter installed in the lamp power supply.From the manufacturer's analysis, it is considered that the cause of the estimation is that the ignition voltage dropped due to the proximity of the parts inside the igniter.The repaired product was returned to the hospital.

• Brand Name: PENTAX
• Common Device Name: VIDEO PROCESSOR
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 11103052
• Report Number: 9610877-2020-00152
• Device Sequence Number: 4037146
• Product Code: PEA
• UDI-Device Identifier: 04961333240197
• UDI-Public: 04961333240197
• 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: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2020

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: 07/25/2020
• Initial Report FDA Received Date: 12/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1