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

Model Number EG29-I10C

Device Problems Display Difficult to Read (1181); Fluid/Blood Leak (1250); Moisture Damage (1405)

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

Event Date 04/27/2021

Event Type  malfunction  

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.Evaluation summary it was caused due to a condensation of moisture in the ccd unit by changing the temperature outside of the endoscope.And, it was caused due to an excessive force applied on the lg cable connector assy.In addition, we confirmed that the lcb distal cover glass dirt, the light guide cable buckle, and the suction channel buckle; these are not related to the alleged complaint.Replaced parts in this complaint are as follow.Defective due to ccd module.Lcb distal cover glass due to dirty.Light guide cable due to buckled.Suction channel due to buckled.Lg cable connector assy due to broken.This report is being filed as part of the pentax backlog management plan.

Event Description

Image is dark, there is moisture under the led cover.The connecting pins are leaky this event occurred at the time of during inspection there was no report of patient harm.

• 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: 12200844
• MDR Text Key: 262670419
• Report Number: 9610877-2021-10243
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333248483
• UDI-Public: 04961333248483
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2021

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: 04/27/2021
• Initial Date FDA Received: 07/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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