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

Model Number	GIF-XP180N
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to an olympus service center for evaluation and the reported issue was a sporadic failure (failure could not be confirmed but occurrence was likely.The biopsy channel/forceps channel had a slow leak due to damage (scraped) due to repeated insertion/removal of a brush or endotherapy accessory.It was likely the scope was insufficiently or incorrectly reprocessed and used for next procedure.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported to olympus, the biopsy channel on the evis exera ii gastrointestinal videoscope may have been torn as some black materials were coming out the scope.The issue was found during maintenance in the reprocessing room.No reported patient harm involvement.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the event was unable to be identified; however, the event most likely occurred due to the forceps channel becoming ruptured during user handling and material inside the endoscope escaped through the rupture.The event can be detected/prevented by following the instructions for use which state the following: "if a stream of air bubbles is emitted from the air/water nozzle even though the air/water valve is not being operated and the distal end of the insertion tube is 10 cm or more below the surface of the sterile water, there may be an irregularity in the air feeding function.If the endoscope is used while air is continuously fed, over-insufflation and patient injury may result.If air bubbles are emitted from the air/water nozzle, remove and reattach the air/water valve correctly, or replace it with a new one.If this fails to stop air bubbles from being emitted, do not use the endoscope, as there may be a malfunction.Contact olympus." " when inserting or withdrawing an endotherapy accessory, confirm that its distal end is closed or completely retracted into the sheath.Slowly insert or withdraw the endotherapy accessory straight into or from the slit of the biopsy valve.Otherwise, the biopsy valve or instrument channel may be damaged and pieces of it could fall off.It may cause patient injury." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
• Common Device Name: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14841684
• Report Number: 8010047-2022-10911
• Device Sequence Number: 16739718
• Product Code: FDS
• UDI-Device Identifier: 04953170339097
• UDI-Public: 04953170339097
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K100584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

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
• Operator of Device: Health Professional
• Device Model Number: GIF-XP180N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown