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	07/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Import for export.International medical device regulators forum (imdrf) adverse event reporting.(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 before use, a strange noise was heard, a spark was witnessed, and the lamp did not turn on.(error code: 03-4000) no damage due to abnormal noise and sparks.We replaced it with a substitute on (b)(6) 2020 and confirmed the reproduction in mitaka." 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 failure was confirmed.Software version: (b)(4).System life: 487 hours 3 minutes 5 seconds.Total lighting time: 212 hours 5400 seconds.Number of lighting: 1331 times.Number of initialization executions: 0 measures against dust on lamp power board: not supported.Door change: already supported.There was a lamp power failure due to dust.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: 11103289
• Report Number: 9610877-2020-00153
• Device Sequence Number: 14462352
• 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): 07/13/2020

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: 07/13/2020
• 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