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

Model Number EG29-I10C

Device Problems Leak/Splash (1354); Defective Component (2292); Material Deformation (2976); Naturally Worn (2988)

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

Event Date 05/27/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the defect was returned.We confirmed that the pve connector leak and the suction channel buckled, the ift bump, and u/d and r/l pulley wire worn out based on our investigation of the returned defect.This device is classified as import for export, therefore 510k is not applicable.Model eg29-i10c-us is available in the usa with a 510k number k190805.This report is being filed as part of the pentax backlog management plan.

Event Description

This event occurred during inspection.There was no report of patient harm.Led board defective, pve connector leaky - with test pcb the led is ok.Sold date (b)(6) 2019, last repair 2021-03-12.

• 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
• 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 ; 3 paragon drive; montvale, NJ 07645 ; 0804315880
• MDR Report Key: 12178904
• MDR Text Key: 261944337
• Report Number: 9610877-2021-10090
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333248483
• UDI-Public: 04961333248483
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1