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

Model Number EG36-J10UR

Device Problem Obstruction of Flow (2423)

Patient Problem Insufficient Information (4580)

Event Date 07/09/2021

Event Type  malfunction  

Manufacturer Narrative

This model is not distributed in the united states, therefore 510k is not applicable.We do have similar model eg36-j10ur-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.

Event Description

Pentax medical was made aware of a complaint which occurred in the (b)(6) region.The information provided indicated that while using pentax medical video gastroscope, model eg36-j10ur, serial number (b)(4), that there was insufficient air/water insufflation.The air/water channels were clogged.Service noted that the air / water channel system will be replaced as part of the service request.

• Brand Name: PENTAX
• Type of Device: 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
• MDR Report Key: 12321711
• MDR Text Key: 282389193
• Report Number: 9610877-2021-00503
• 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: user facility
• Type of Report: Initial
• Report Date: 08/13/2021

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: EG36-J10UR
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/14/2021
• Initial Date FDA Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1