MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; DIGITAL LINEAR ULTRASOUND SCOPE

Model Number EG38-J10UT

Device Problems Erratic or Intermittent Display (1182); Poor Quality Image (1408)

Patient Problem Insufficient Information (4580)

Event Date 07/12/2021

Event Type  malfunction  

Event Description

Pentax medical was made aware of a report which occurred in the workshop during inspection in the (b)(6) region.The reported complaint was for "image interference and oversaturation when the ccd chip is heated" involving pentax medical video gastroscope model eg38-j10ut, serial number (b)(4).No further information was provided at the time of the report.The endoscope requires a ccd (charged couple device) replacement as part of the service repair.On 28-jul-2021, a device history record(dhr) review for model eg38-j10ut, serial number (b)(4), was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured in the (b)(4) facility on 28-aug-2020 under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed for 28-aug-2020.

Manufacturer Narrative

This model is not distributed in the united states, therefore 510k is not applicable.We do have similar model eg38-j10ut-us available in the united states with a 510k number k200090.(b)(4).If additional information becomes available, a supplemental report will be filed with the new information.

• Brand Name: PENTAX
• Type of Device: DIGITAL LINEAR ULTRASOUND SCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12301227
• MDR Text Key: 282837685
• Report Number: 9610877-2021-00263
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 08/09/2021

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
• Device Operator: Health Professional
• Device Model Number: EG38-J10UT
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1