MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II DUODENOVIDEOSCOPE

Model Number TJF-Q180V

Device Problem Corroded (1131)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

The device in this report has not been investigated by the manufacturer yet.Therefore the exact cause of the reported has not been conclusively determined.This report will be supplemented once the investigation has been concluded.

Event Description

A technical service engineer of olympus medical systems (b)(4) private limited reported that there was corrosion inside the light guide lens at the distal end of the endoscope.No patient was involved in this event.There is no other information provided at this moment.This report will be supplemented if additional information is available.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation, but was returned to olympus medical systems india private limited (omsi).Omsi found a perforation in the bending section during incoming inspection.The subject device failed air leak test due to the perforation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.There is no service record for the subject device in the last four years.The exact cause of the reported phenomena could not be conclusively determined.However, based upon the inspection, the reported phenomenon could have been attributed to fluid ingress through around the light guide lens due to physical stress, chemical stress, poor storage condition such as direct sun light, high temperature, x-ray, and ultra violet ray, or aging deterioration.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11092941
• MDR Text Key: 225334590
• Report Number: 8010047-2020-11116
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170367311
• UDI-Public: 04953170367311
• Combination Product (y/n): N
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1