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

Model Number EG29-I10C

Device Problems Loss of or Failure to Bond (1068); No Display/Image (1183); Fluid/Blood Leak (1250); Moisture Damage (1405); Use of Device Problem (1670); Optical Distortion (3000)

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

Event Date 09/16/2021

Event Type  malfunction  

Event Description

The images fades over, the electrical safety test failed, there is moisture inside the cmos chip.This event occurred at the time of before use.There was no report of patient harm.

Manufacturer Narrative

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.If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

Evaluation summary: the cmos chip and the distal body replaced.

• 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 ; 8004315880
• MDR Report Key: 12595416
• MDR Text Key: 280997469
• Report Number: 9610877-2021-01194
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333237586
• UDI-Public: 04961333237586
• 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,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• 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: 09/16/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/25/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1