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

Model Number	EPK-I5500C
Medical Device Problem Code	Erratic or Intermittent Display (1182)
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.Evaluation summary: it was caused due to the insufficient connection between the scope connector and the processor socket.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.All merchandise epk-i5500c imagina processor have to be check to ensure they have the latest software.Upon checking the video image of the processor, the endoscope video image freezes after a slight movement on the scope housing connector, causing intermittent signal connection to the video image due to the scope receptacle being misaligned/loose.Description of any actions taken: currently hold in video dept.And system for further evaluation.Product manager has been informed.

• 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: 12257137
• Report Number: 9610877-2021-10580
• Device Sequence Number: 4066658
• Product Code: PEA
• UDI-Device Identifier: 04961333232918
• UDI-Public: 04961333232918
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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): 07/31/2021

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: 02/10/2021
• Initial Report FDA Received Date: 07/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1