MAUDE Adverse Event Report: HOYA Corporation PENTAX Tokyo Office PENTAX Medical; DEC HD VIDEO DUODENOSCOPE

Model Number	ED34-I10T2
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2026
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(fluid damage).
Additional Manufacturer Narrative
The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the ccd drive pcb fluid damage.Based on the result, we concluded that it was caused due to the fluid damage from the ccd drive pcb.In addition, our technician confirmed that the mechanical base plate fluid damage, the segment broken, the ccd module with drive pcb cloudy (not clear view), the light guide cable buckled, the control body corroded, the operation channel (primary) leak, and the operation channel (primary) resistance; however, these defects are 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: DEC HD VIDEO DUODENOSCOPE
• 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 ; +1(800)431-5880
• MDR Report Key: 50049575
• Report Number: 9610877-2026-51538
• Device Sequence Number: 15825328
• Product Code: FDT
• UDI-Device Identifier: 04961333233007
• UDI-Public: (01)04961333233007(11)210715
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K192245
• 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): 07/28/2026

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: ED34-I10T2
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2021
• 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