MAUDE Adverse Event Report: PENTAX-AOHUA MEDICAL TECHNOLOGIES CO., LTD. PENTAX; ULTRASOUND GASTROSCOPE

Model Number	EG27-V10C
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Import for export.(b)(4).
Event or Problem Description
During evaluation by the pentax medical service repair department on 06-feb-2020, an "accessory stuck in primary operation channel" was identified involving model eg27-v10c, serial number (b)(4), and the complaint handling unit was notified.On 26-may-2020, communications between pentax medical complaint handling unit and marketing product manager along with the assets and used equipment coordinator established the endoscope was delivered to (b)(6) on (b)(6) 2019 as a demo unit and returned on 08-aug-2019.Marketing confirmed the device was not available for sales in the united states and that there is no known patient involvement involving this demo unit, and no patient risk.The pentax medical service repair technician documented an "accessory stuck in primary operation channel" documented under service order (b)(4) on 06-feb-2020.Other inspectional findings included: primary operation channel resistance, passed wet leak test, passed dry leak test.The investigation and repair is in-process.

• Brand Name: PENTAX
• Common Device Name: ULTRASOUND GASTROSCOPE
• Manufacturer (Section D): PENTAX-AOHUA MEDICAL TECHNOLOGIES CO., LTD.; no 5 shenwang road; east of 3rd fl, block c, bld 1; minhang district, shanghai 20110 8; CH 201108
• MDR Report Key: 10840098
• Report Number: 9610877-2020-00218
• Device Sequence Number: 3525643
• Product Code: ODG
• UDI-Device Identifier: 04961333244676
• UDI-Public: 04961333244676
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/06/2020

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: EG27-V10C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1