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

Model Number EG36-J10UR

Device Problem No Display/Image (1183)

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

Event Date 08/11/2021

Event Type  malfunction  

Manufacturer Narrative

This device is classified as import for export, therefore 510k is not applicable.Similar model eg36-j10ur-us is available in the usa 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 an event which occurred in the pai region involving pentax video ultrasound scope eg36-j10ur-us.In the event reported, it was stated that there was no ultrasound image.The timing of this anomaly is not known.There was no adverse event reported with this complaint.The device was returned to pentax medical on service order (b)(4) and evaluated by the technician where the user narrative was not confirmed.Inspection findings are as follows: fluid invasion in ultrasound connector; passed dry leak test; passed wet leak test; customer complaint not duplicated; corroded ultrasound connector body.This device is currently pending repairs for the defects found.Parts to be replaced: o-rings and seals; us connector body; o-ring special for us connector a review of the service history indicates the device was not routinely serviced at a pentax facility.On 26-aug-2021, a device history record (dhr) review for model eg36-j10ur, serial number (b)(4) was performed and the dhr review confirmed the endoscope was manufactured on 20aug2020 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.

Manufacturer Narrative

Correction information: g6: follow up #1; h2:if follow-up, what type?; h6: coding changed based on the investigation result (health effect - clinical code, health effect - impact code).

• 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
• 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: 12449032
• MDR Text Key: 283494836
• Report Number: 9610877-2021-00617
• Device Sequence Number: 1
• Product Code: ODG
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/14/2022

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: EG36-J10UR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 08/11/2021
• Supplement Dates FDA Received: 10/14/2022
• 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