MAUDE Adverse Event Report: PENTAX Medical Corporation PENTAX Medical; PENTAX Medical Video Upper GI Scope EG29-i20c

Model Number	EG29-i20c
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2026
Type of Reportable Event	Malfunction

• Brand Name: PENTAX Medical
• Common Device Name: PENTAX Medical Video Upper GI Scope EG29-i20c
• Manufacturer (Section D): PENTAX Medical Corporation; 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 ; tsutsujigaoka 1-1-110; akishima-shi, tokyo, NJ 196-0-012 ; JA 196-0012 ; +1(800)431-5880
• MDR Report Key: 50081161
• Report Number: 9610877-2026-00041
• Device Sequence Number: 10342423
• Product Code: FDS
• UDI-Device Identifier: 04961333251858
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K231249
• 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,Followup
• Report Date (Section B): 09/29/2026

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: EG29-i20c
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2025
• 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