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

Model Number EPK-I5500C

Device Problem Data Problem (3196)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

We didn't get any information.This device is classified as import for export, therefore 510k is not applicable.Model epk-i5500c-us is available in the usa with a 510k number k190805.The device was returned, but it's still under investigation,so the results of the investigation will be provided in a supplemental report.

Event Description

An error occurred during initialization of patient database, error code 002-0006.This event occurred at the time of during inspection.There was no report of patient harm.

Manufacturer Narrative

Evaluation summary: as the device was returned but it has been still under investigation, we will continue to monitor it and create a supplemental report if necessary.Correction information: g6: follow up #1.H3: device evaluation.Additional information: h2: type of follow up.H6: coding added based on the investigation result: type of investigation, investigation findings, and investigation conclusions.This report is being filed as part of the pentax backlog management plan.

• Brand Name: PENTAX
• Type of Device: 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: 12133025
• MDR Text Key: 260428965
• Report Number: 9610877-2021-10011
• Device Sequence Number: 1
• Product Code: PEA
• UDI-Device Identifier: 04961333232918
• UDI-Public: 04961333232918
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EPK-I5500C
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other