MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO UPPER GI SCOPE

Model Number EG-2990I

Device Problem Mechanical Problem (1384)

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

Event Date 12/31/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the device was noted to be leaking after the procedure.The device was sent to a third party for evaluation.This complaint is being processed in accordance with dpa-qip-mdr decision backlog management plan.

Event Description

It was reported that after the procedure, the doctor found that the scope was leaking.The issue was observe on a eg-2990i- video upper gi scope, in the operating room, after a procedure.It was immediately reported to the equipment department and the scope was sent to third party for repair.

• Brand Name: PENTAX
• Type of Device: VIDEO UPPER GI SCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12355641
• MDR Text Key: 282797823
• Report Number: 9610877-2021-00708
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• PMA/PMN Number: K131902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 08/22/2021

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: EG-2990I
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/31/2020
• Initial Date FDA Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1