MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; IMAGINA PROCESSOR (INCLUDES I-SCAN)-INT

Model Number	EPK-I5500C
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is classified as import for export, therefore 510k is not applicable.Model epk-i5500c is available in the usa with a 510k number k190805.Evaluation summary- it was caused the software error.This report is being filed as part of the pentax backlog management plan.
Event or Problem Description
This event occurred at the time of before use.There was no report of patient harm.Entry of patient data not possible.Error message: an error occurred during initialization of patient database, and additional system error 002-0006(patient_database_error).

• Brand Name: PENTAX
• Common Device Name: IMAGINA PROCESSOR (INCLUDES I-SCAN)-INT
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12272347
• Report Number: 9610877-2021-10520
• Device Sequence Number: 19715874
• Product Code: PEA
• UDI-Device Identifier: 04961333232918
• UDI-Public: 04961333232918
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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-I5500C
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2021
• 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