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

Model Number	EPK-I5500C
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: it was caused due to the part failure in the processor.This device is classified as import for export, therefore 510k is not applicable.Epk-i5500c-us is available in the usa with a 510k number k190805.This report is being filed as part of the pentax backlog management plan.
Event or Problem Description
It is a processor that takes dozens of pictures intermittently, freezes, and blacks out during procedures.User told that the problem is in the receptacle on the processor.There was no report of patient harm.Date of event not known for the exact date, we just know the year the complaint was sent in to manufacturer.
Additional Manufacturer Narrative
9610877-2021-10639 submitted on 29-jul-2021 was found to be a duplicate of 9610877-2021-00045 submitted on 03-aug-2021.9610877-2021-10639 submits a supplemental report as invalid.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

• 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
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale; nj 07645 ; 8004315880
• MDR Report Key: 12243729
• Report Number: 9610877-2021-10639
• Device Sequence Number: 4600336
• Product Code: PEA
• UDI-Device Identifier: 04961333232918
• UDI-Public: 04961333232918
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 08/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown