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

Model Number	EPK-I5500C
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is classified as import for export, therefore 510k is not applicable.Model epk-i5500c-us is available in the usa with 510k number k190805.Serial number is unavailable.Evaluation summary- the default setting of the profile on this device is that max and min are displayed in english.Even if the users change the language notation to french, max and min remain in english notation; however, if they change the default settings, max and min can also change to the french notation.This complaint is a product specification issue.This report is being filed as part of the pentax backlog management plan.
Event or Problem Description
The time of event is unknown.There was no report of patient harm.Bug at the language selection on the touch screen.A small problem on the selection of profiles "max/min" on the epk-i5500c, the profile "min" remains in english, even if you selected french for the profile "max".You are obliged to re-select french for the "min" profile for it to appear in french.

• 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: 12278855
• Report Number: 9610877-2021-10578
• Device Sequence Number: 5403739
• Product Code: PEA
• UDI-Device Identifier: 04961333232918
• UDI-Public: 04961333232918
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/05/2021

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1