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

Model Number EG29-I10C

Device Problems Electrical /Electronic Property Problem (1198); Optical Distortion (3000); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2021

Event Type  malfunction  

Event Description

This event occurred at the time of before use.There was no report of patient harm.Iso failed, misty image, led cover glass broken.

Manufacturer Narrative

This device is classified as import for export, therefore 510k is not applicable.Model eg29-i10c is available in the usa with a 510k number k190805.Evaluation summary: we checked the returned product and confirmed that it was caused due to a leak at the led cover glass by a physical damage.Due to the leak,it caused that the electrical safety test in emea to fail.This report is being filed as part of the pentax backlog management plan.

• 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: 12351824
• MDR Text Key: 283093682
• Report Number: 9610877-2021-10534
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333248483
• UDI-Public: 04961333248483
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 08/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2021
• 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
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1