MAUDE Adverse Event Report: HOYA Corporation PENTAX Tokyo Office PENTAX Medical; DIGITAL RADIAL ULTRASOUND SCOPE

Model Number	EG36-J10UR
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2026
Type of Reportable Event	Malfunction

• Brand Name: PENTAX Medical
• Common Device Name: DIGITAL RADIAL ULTRASOUND SCOPE
• 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: 50064960
• Report Number: 9610877-2026-51550
• Device Sequence Number: 10206999
• Product Code: ODG
• UDI-Device Identifier: 04961333239535
• UDI-Public: (01)04961333239535(11)210209
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K200090
• 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): 07/29/2026

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: EG36-J10UR
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2021
• 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