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

Model Number	EPK-3000
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: this defect is not reproducible.This is random failure.In addition, we confirmed that the scope connector unit broken; however, it is not related to the alleged complaint.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
This event occured during use.There was no report of patient harm.Retry - c function.Freeze release - f function of fr2-key on kbd where error messages occur frequently.The lock lever is stiff.

• Brand Name: PENTAX
• Common Device Name: VIDEO PROCESSOR (INTERNATIONAL)
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYON OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 19600 12; JA 1960012
• MDR Report Key: 12200819
• Report Number: 9610877-2021-10116
• Device Sequence Number: 14563092
• 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): 07/21/2021

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: 05/21/2021
• Initial Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other