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 Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2021

Event Type  malfunction  

Event Description

Pentax medical was made aware of a complaint which occurred in the united states.The customer reported there was an "intermittent flickering image" involving pentax medical ultrasound video gastroscope, model eg38-j10ut, serial number (b)(4).The timing and location of the issue observed are unknown.There was no report of death, serious injury or any event requiring medical intervention.

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 customer owned endoscope was assigned rma (b)(4) but has not been received by pentax medical for evaluation as of 23-nov-2021.Model eg38-j10ut, serial number (b)(4) has not been previously returned for serviced at a pentax facility since the device was put into service.On (b)(6) 2021, 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 18-oct-2019 under normal conditions, passed at the second inspection for replacement of udi-plate, 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 18-oct-2019.The investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

Evaluation summary: the cause is possible disconnection of the ccd cable due to repeated use.Correction information: g4: premarket identification pma/510(k) 510k number is not applicable.G6: follow up #1 h2: type of follow up h3: device evaluated h6: coding changed based on the investigation result.

• 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: 12865745
• MDR Text Key: 286646516
• Report Number: 9610877-2021-01499
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• 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?: Yes
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1