MAUDE Adverse Event Report: PENTAX OF AMERICA , INC. PENTAX; PENTAX MEDICAL VIDEO PROCESSOR EPK-I8020C

Model Number	EPK-I8020C
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pentax medical emea performed a good faith effort (gfe) to gather additional information regarding this event and received a response via email on 15-oct-2025.The same phenomenon occurred with three processors, and all procedures were stopped before completion.Investigation is in process.If additional information becomes available, a supplemental report will be filed with the new information.Related mdr numbers: 9610877-2025-00200_epk-i8020c_f0158z0062_the screen turns red during bleeding.9610877-2025-00201_epk-i8020c_e0158z0139_the screen turns red during bleeding.9610877-2025-00202_epk-i8020c_e0158z0055_the screen turns red during bleeding.
Event or Problem Description
On (b)(6) 2025, pentax medical became aware of an event involving a pentax medical video processor model epk-i8020c, serial number (b)(6) in spain within the emea region.When used for bleeding cases, the endoscopic image displayed by the processor appeared strongly reddish.This event occurred at the time of during use.There was no report of patient harm.This event meets the requirements for fda reportability; however, submission of this report does not constitute an admission that medical personnel, user facility, importer, manufacturer, or product caused or contributed to the event.
Additional Manufacturer Narrative
Correction information b4: date of this report - updated g6: follow-up #: 1 h2: if follow-up, what type? - updated h3: device evaluated by manufacturer - "no" to "yes" h6: codes updated - component code, type of investigation, investigation findings, investigation conclusions.Additional information d4: primary unique device identifier (udi) h4: device manufacture date h11: evaluation summary.Evaluation summary the reported event was that the image appeared excessively red.Based on the investigation, it was considered that the eb19-j10u was used in a case involving bleeding, and blood covering the objective lens resulted in a red image.A definitive root cause of the reported issue could not be identified.According to the video attached to the complaint, wiping the endoscope tip with gauze restored the image to normal, and blood was observed on the gauze.To date, no patient harm has been reported related to this issue.A device history record (dhr) review was performed by the manufacturer.The dhr review confirmed that the endoscope was manufactured at miyagi on 07-jan-2025 under normal conditions.During the final inspection, scrtch (scratches, cracks in paint or finish) was detected, and the tracked subassembly was replaced.However, it was confirmed that the endoscope passed all required inspections and was released accordingly.The dates of approval for shipment and the actual date shipped were confirmed on 27-jan-2025.Related mdr numbers: 9610877-2025-00200_epk-i8020c_(b)(6)_the screen turns red during bleeding_fu1, 9610877-2025-00201_epk-i8020c_(b)(6)_the screen turns red during bleeding_fu1, 9610877-2025-00202_epk-i8020c_(b)(6)_the screen turns red during bleeding_fu1.

• Brand Name: PENTAX
• Common Device Name: PENTAX MEDICAL VIDEO PROCESSOR EPK-I8020C
• Manufacturer (Section D): PENTAX OF AMERICA , INC.; 3 paragon drive; montvale NJ 07645
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: gurvinder nanda ; 3 paragon drive; montvale, NJ 07645 ; 2015712318
• MDR Report Key: 23411961
• Report Number: 9610877-2025-00201
• Device Sequence Number: 8945855
• Product Code: PEA
• UDI-Device Identifier: 04961333254934
• UDI-Public: (01)04961333254934(11)250107
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K231249
• 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): 12/16/2025

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-I8020C
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2025
• 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