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

Model Number	EPK-3000
Medical Device Problem Code	Failure to Transmit Record (1521)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is classified as import for export, therefore 510k is not applicable.Modelepk-3000-us is available in the usa with a 510k number k172156.As a result of the dhr investigation, it was returned due to out of box failure, repaired (e board replacement), and reshipped.After receiving the complaint, a reproducibility test was conducted.Electronic scope used: vnl-j10 (s / n: (b)(4)) the reproduction test was carried out under the following conditions with reference to the error frequency and the number of times (about 80 times) from the log information.With the electron scope inserted, turn on the power of the main unit.When the image appears normally, repeat the action of turning the power off and then on again 100 times.Result: performed 100 times, but the error code "03-0040" did not occur.Since it does not reproduce, the pre-process board was replaced as a preventive measure.
Event or Problem Description
Error code 03-0040 occurred when connecting to scope before use.There is only one scope and it does not occur with the other epk-3000.Since it occurred before use, there is no health hazard to patients and medical staff.

• 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: 12119623
• Report Number: 9610877-2021-10037
• Device Sequence Number: 3652355
• 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): 07/06/2021

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: 06/07/2021
• Initial Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1