MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-Q180

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned and the evaluation found no other reportable malfunctions aside from the allegation reported in b5.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the gastrointestinal videoscope exhibited a situation where body fluids or filth had leaked or presented a risk of leakage from the biopsy valve (air/water valve, suction valve, or auxiliary water inlet).The issue was found during preparation for use for an unknown procedure.There were no reports of patient harm.

Manufacturer Narrative

This supplemental report is being submitted to provide the legal manufacturer's final investigation.Additional information: h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over fourteen (14) years since the subject device was manufactured.A definitive root cause was not identified, however based on the results of the investigation, the probable cause of the "leakage of body fluids or filth from the biopsy valve, air/water valve, suction valve or auxiliary water channel port¿ malfunction would likely be related to the reprocessing that was not conducted properly due to leakage from biopsy channel.The event can be prevented by following the instructions for use which state: ifu states that detection method in evis exera ii gif/cf/pcf type 180 series operation manual chapter 3 preparation and inspection.Ifu states that preventive measure in evis exera ii gif/cf/pcf type 180 series reprocessing manual chapter 5 reprocessing the endoscope (and related reprocessing accessories).Three attempts were made to obtain additional information regarding the reported event, but no response was received from the customer.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18865335
• MDR Text Key: 337628632
• Report Number: 9610595-2024-05015
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170202247
• UDI-Public: 04953170202247
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-Q180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1