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

Model Number TJF-Q180V

Device Problems Corroded (1131); Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has been returned to olympus for physical evaluation.Preliminary findings are reported.The definitive cause of the customer's experience can not be determined at this time.The investigation is ongoing.Physical evaluation of the complaint device reveals the following: leaking was noted between c-body and c-cover.Corrosion was noted on the c-body, unable to remove.Corrosion was noted inside the lens.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported during yearly inspection of a evis exera ii duodenovideoscope, the elevator was broken and possible rust was identified.There was no reported patient contact/impact related to this event.

Manufacturer Narrative

This reported is being updated to provide investigation findings and additional information provided by the customer.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.The instructions for use (ifu) shipped with the device provides the user the following information related to the reported event: important information ¿ please read before use: warnings and cautions: do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.Conclusion: the definitive cause of the user's experience could not be determined.Based on the available information the following are the presumed possible causes: physical stress caused by hitting the distal end against an object.Chemical stress caused by chemical solution used in reprocessing.Storage environment.

• 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: 10971817
• MDR Text Key: 227200802
• Report Number: 8010047-2020-10060
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

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: TJF-Q180V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1