MAUDE Adverse Event Report: PENTAX Medical Corporation PENTAX Medical; IMAGINA COLONOSCOPE (US ONLY)

Model Number	EC38-I10CL
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The time of event is unknown.There was no report of patient harm.Video image failure (cloudy).
Additional Manufacturer Narrative
Effective august 1, 2026, mdr-related activities and responsibilities were transferred to pentax medical corporation as part of a corporate restructuring.This report is being submitted by pentax medical corporation.In accordance with 21 cfr 803.3(m), because this corporate restructuring does not affect the manufacturing site, the fda registration number previously assigned for this site (#9610877) continues to be used.The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the cmos module with drive pcb signs of fluid droplets on the video image.Based on the result, we concluded that it was caused due to the moisture condensation in the cmos module with drive pcb.In addition, our technician confirmed that the led cover glass signs of moisture or fluid under the cover glass; however, this defect is not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report "hr-rpt-0586(image failure)" and/or the risk analysis results, it was evaluated to submit mdr.

• Brand Name: PENTAX Medical
• Common Device Name: IMAGINA COLONOSCOPE (US ONLY)
• Manufacturer (Section D): PENTAX Medical Corporation; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer (Section G): PENTAX Medical Corporation; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: paresh patel ; 3 paragon drive; montvale, NJ 07645 ; +1(800)431-5880
• MDR Report Key: 50893621
• Report Number: 9610877-2026-52000
• Device Sequence Number: 13439827
• Product Code: FDF
• UDI-Device Identifier: 04961333248513
• UDI-Public: (01)04961333248513(11)230207
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K190805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: EC38-I10CL
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2023
• 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