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

Model Number EG38-J10UT

Device Problem No Display/Image (1183)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Pentax medical was made aware of a complaint that occurred in the united states.The customer reported no video image involving pentax medical ultrasound gastroscope, model eg38-j10ut, serial number (b)(4).The event timing and location are unknown.No death or serious injury was reported.This event meets the requirements for fda reportability; however submission of this report does not constitute an admission that medical personnel, user facility, importer, manufacturer or product caused or contributed to the event.

Manufacturer Narrative

This model is classified as import for export and 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) _ the endoscope will be evaluated by pentax medical.Once evaluation is completed the device will be repaired and returned to the customer or loaner inventory as applicable.Model eg38-j10ut, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service on 18-jan-2022, 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 20-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 20-aug-2020.The investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

During pentax internal review, the same event was filed under mdr (9610877-2022-00216) which was submitted.Therefore, mdr (9610877-2022-00192) filed on feb-11-2022 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: 13518775
• MDR Text Key: 296224944
• Report Number: 9610877-2022-00192
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: REFER TO H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2022
• Date Device Manufactured: 08/20/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1