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

Model Number EG38-J10UT

Device Problem Poor Quality Image (1408)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Pentax model  eg38-j10ut is classified as import for export, therefore 510k is not applicable.Same pentax model eg38-j10ut-us is distributed in the usa with 510k number k200090.If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Pentax medical became aware of a report for an event which occurred in (b)(6) stating, "interferences in the us image" involving pentax model eg38-j10ut/serial (b)(4).The event was reported to have occurred prior to use.No further information was provided at the time of the report.The device was returned to pentax medical (b)(4) service workshop where the customer complaint could not be confirmed.

• 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: 12351844
• MDR Text Key: 280832032
• Report Number: 9610877-2021-00498
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• PMA/PMN Number: REFER TO H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 08/21/2021

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: 07/23/2021
• Initial Date FDA Received: 08/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1