MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; PENTAX MEDICAL VIDEO COLONOSCOPE EC34-I20C SERIES

Model Number	EC34-I20CL
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
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 - type of investigation, investigation findings, investigation conclusions.Additional information: d4: primary unique device identifier (udi).H4: device manufacture date.H7: 7.If remedial action initiated, check type.H9: if action reported to fda under 21 usc 360i(g), list correction/removal reporting number.H11: evaluation summary.Evaluation summary: the reported event was poor image quality, insufficient illumination, and deposits observed on the lens.A device history record (dhr) review was performed by the manufacturer.The dhr review confirmed that the endoscope was manufactured at miyagi on 22-oct-2025 under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions, and the actual date shipped was confirmed as 27-nov-2025.Based on the investigation, a potential root cause of this failure is considered to be adhesion of organic matter to the distal-end light cover glass, followed by coagulation due to the thermal energy generated by the illumination.Information obtained through user interview confirmed that the endoscopic procedure was performed on a patient with residual organic matter without using light limit mode.Therefore, it was concluded that light limit mode was not used in accordance with the ifu.A corrective and preventive action (capa) remains open to address this issue.Based on the trend analysis, there is no significant increase or upward trend in repair complaints related to this failure mode or hazard.No additional patient harm has been reported to date.Remedial action: this event is currently undergoing remedial action under fca report 2518897-01/20/2025-001-c.Please refer to the fca report for details on the root cause investigation and corrective actions.The remedial action includes revisions to the instructions for use (ifu) and enhanced user warnings.Pentax medical has not received any further information for this event and therefore considers this medwatch report closed.
Event or Problem Description
On 10-apr-2026, pentax medical became aware of an event involving a pentax medical video colonoscope model ec34-i20cl, serial number (b)(6) in ireland within the emea region.During a colonoscopic procedure, when the endoscope reached the caecum, the endoscopic image became grainy and reddish.When the endoscope was withdrawn from the patient, the distal end of the endoscope was found to be hot, and waste matter had adhered and coagulated on the illumination lens at the distal end.The physician performed a biopsy on an area considered to be a suspicious lesion due to the deterioration in image quality, however the area was identified as fecal matter.The procedure was completed using a replacement endoscope, but the procedure time was extended.The physician reported that the deterioration of the endoscopic image interfered with the procedure and that the endoscope was not used for the remaining procedures on that day.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
The reported event was that the endoscopic image became grainy and reddish when the endoscope reached the cecum during a colonoscopic procedure.The procedure time was extended and the procedure was completed using a replacement endoscope.Pentax medical emea performed gfe to gather additional information regarding this event and received responses to its inquiries via email on 14-apr-2026.According to information obtained from the user facility, no active bleeding was observed prior to reaching the cecum.Debris was observed adhering and coagulating on the illumination lens at the distal end of the endoscope after withdrawal, and the distal end was found to be hot.It was also reported that light limit mode (llm) was not used during the procedure.The processor used during the procedure was epk-i8020c (serial number (b)(6) with software version 0107c-1.0060.The availability of the device for evaluation is currently unknown.Investigation is in process.If additional information becomes available, a supplemental report will be filed with the new information.

• Brand Name: PENTAX
• Common Device Name: PENTAX MEDICAL VIDEO COLONOSCOPE EC34-I20C SERIES
• 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: paresh patel ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 25055057
• Report Number: 9610877-2026-00022
• Device Sequence Number: 10101046
• Product Code: FDF
• UDI-Device Identifier: 04961333356416
• UDI-Public: (01)04961333356416(11)251022
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K241213
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2026

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: EC34-I20CL
• Device Lot Number: A003EA0269
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2518897-01/20/2025-001-C
• Patient Sequence Number: 1
• Patient Sex: Female