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

Model Number EG38-J10UT

Device Problem Erratic or Intermittent Display (1182)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

Import for export.(b)(4).If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Pentax medical was made aware on (b)(6) 2021 of a report which occurred in the workshop during inspection in the (b)(6) region.The reported complaint was for "image disturbance during angulation no image visible", 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.

• 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: 12162843
• MDR Text Key: 280572481
• Report Number: 9610877-2021-00187
• 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: distributor,foreign,user faci
• Type of Report: Initial
• Report Date: 07/13/2021

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: 06/15/2021
• Initial Date FDA Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1