MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX MEDICAL; SLIM COLONOSCOPE I20C SERIES

Model Number	EC34-I20CL
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the lcb distal cover glass dirty.In addition, our technician confirmed that the insertion flexible tube crushed, the bending rubber leak, and the bending rubber cut; however, these defects are not the main cause, and/or irrelevant to the alleged complaint.Based on the result, we concluded that it was caused due to the organic material such as the patient's blood or stool adhered to the tip of the scope, causing heat from the light to accumulate at the tip on the lcb distal cover glass.Event that occurred is temperature rise at the tip of the scope.Based on the investigation, a potential root cause of this failure is during the examination, organic matter such as the patient's blood or stool adhered to the tip of the scope, causing heat from the light to accumulate at the tip.A definitive root cause of the reported issue could not be identified.Following the results of the investigation, hra (health hazard evaluation and health risk assessment) was performed.According to hra (hv-hra-0184), since the residue adhered to the illumination lens of the endoscope, it is assumed that the adhered residue coagulated and solidified on the illumination lens as it absorbed the illumination light and was heated, resulting in the endoscopic image to become darker.The results of the desk test suggested that minor burns may occur if the endoscope is pressed against a mucous membrane for a certain period of time (more than 3 seconds) while the lens is covered with blood and the temperature of the distal end of the endoscope is elevated.However, there were no actual complaints of mucous membrane burns.Some medical experts pointed out that some physicians who are not familiar with the endoscopy procedure may have the distal end of the endoscope contact the mucous membrane for a certain period of time when inserting the endoscope into the patient's body.After the in-house review, this case was determined that mdr is necessary.
Event or Problem Description
The time of event is unknown.There was no report of patient harm.Lcb distal cover glass dirty.

• Brand Name: PENTAX MEDICAL
• Common Device Name: SLIM COLONOSCOPE 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: 24288768
• Report Number: 9610877-2026-50327
• Device Sequence Number: 10324305
• Product Code: FDF
• UDI-Device Identifier: 04961333356416
• UDI-Public: (01)04961333356416(11)250203
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K214213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/09/2026

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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