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 01/18/2022

Event Type  malfunction  

Manufacturer Narrative

This device is classified as import for export, therefore 510k is not applicable.Similar model eg38-j10ut-us is available in the usa with a 510k number k200090.The device was received at pentax on service order (b)(4) where the user narrative was confirmed.The device is in the process of getting repaired and will be returned to the user upon completion.On 07-feb-2022, a device history record (dhr) review for model eg38-j10ut, serial number (b)(4) was performed and the dhr review confirmed the endoscope was manufactured on 02mar2021 under normal conditions, failed in process inspection and was reworked for b-body assembly and subsequently pass all required inspections, and was released accordingly.The dates of approval for shipment and actual date shipped were confirmed.If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Pentax medical was made aware of an event which occurred in the pai region involving pentax endoscope model eg38-j10ut.In the event reported, the user stated that there was poor image quality.The event timing is unknown.There was no adverse event reported with this complaint.No other information provided with this complaint.This event meets the requirement for fda reportability; therefore, submission of a report does not constitute an admission that medical personnel, user facility, importer, manufacturer, or product caused or contributed to the event.

Manufacturer Narrative

During pentax internal review, the same event was filed under mdr (9610877-2022-51036) which was submitted.Therefore, mdr (9610877-2022-00310) filed on february 17, 2022 is considered a duplicate report.

• 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
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 13549043
• MDR Text Key: 296148513
• Report Number: 9610877-2022-00310
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04961333239436
• UDI-Public: 04961333239436
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 02/17/2022
• Supplement Dates Manufacturer Received: 01/18/2022
• Supplement Dates FDA Received: 09/14/2022
• Date Device Manufactured: 03/02/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1