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

Model Number EG29-I10C

Device Problems Moisture Damage (1405); Optical Distortion (3000)

Patient Problem Insufficient Information (4580)

Event Date 06/14/2021

Event Type  malfunction  

Event Description

Pentax medical was made aware of a complaint on (b)(6) 2021 for "moisture in the lens, foggy image in the middle of the image" that occurred in the operating room, prior to use in the (b)(6) region involving pentax medical video gastroscope, model eg29-i10c, serial number (b)(4).The information provided indicated that there was no leak.The endoscope has since been inspected at the pmk service center and the customer complaint confirmed.The endoscope is currently awaiting repairs.This event meets the requirements for fda reportability.

Manufacturer Narrative

Import for export.(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: 12166726
• MDR Text Key: 280570761
• Report Number: 9610877-2021-00203
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• 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: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1