MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; IMAGINA GASTROSCOPE

Model Number EG29-I10C

Device Problem Poor Quality Image (1408)

Patient Problem Insufficient Information (4580)

Event Date 08/02/2021

Event Type  malfunction  

Event Description

Pentax medical became aware of a report for an event which occurred in (b)(6) stating, "the foggy image" involving pentax medical endoscope, model eg29-i10c, serial number (b)(4).The event was reported to have occurred prior to use.No further information was provided at the time of the report.The device was returned to pentax medical (b)(4) service workshop and is pending repairs.On 07-sep-2021, a device history record(dhr) review for model eg29-i10c, serial number (b)(4) was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured in the (b)(4) facility on 16-jun-2021 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 16-jun-2021.

Manufacturer Narrative

This model is not distributed in the united states, therefore 510k is not applicable.We do have similar model eg29-i10c-us available in the united states with a 510k number k190805.(b)(4).If additional information becomes available, a supplemental report will be filed with the new information.

• Brand Name: PENTAX
• Type of Device: IMAGINA GASTROSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12448869
• MDR Text Key: 283495330
• Report Number: 9610877-2021-00597
• Device Sequence Number: 1
• Product Code: FDS
• 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: company representative,foreig
• Type of Report: Initial
• Report Date: 09/09/2021

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: EG29-I10C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1