MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. 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)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the evis exera ii gastrointestinal videoscope experienced wrinkles in the connecting tube.The issue was found during customer maintenance.The device was returned for evaluation.During the device evaluation, foreign material was found in the air water nozzle.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the evaluation found the adhesive on the bending section cover was detached, the image guide protector had a cut, the bending section cover was discolored, the water removability did not meet the standard value due to clogging of the nozzle, the control unit had a scratch, the control unit was discolored, the bending angle in the up, down, left, and right direction did not meet the standard value due to wear of the angle wire, the universal cord was buckling, the right left knob had a stain, the up down knob had a stain, switch 1 had a scratch, the play of the right left knob was out of the standard value due to wear of the angle wire, the connecting tube was buckling, the grip had a scratch, and the up down knob was out of the standard value due to wear of the angle wire.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.E1/establishment name: (b)(6) added here due to character limitation in respective field.
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.It has been 10 years since the device was manufactured.Based on the results of the investigation, the event, ¿foreign material came out of the nozzle¿, was confirmed.It could not be specified what the foreign material was nor the root cause of the remaining foreign material.The foreign material possibly remained in the device since the reprocessing steps were not implemented in line with the instructions for use (ifu).Performance of reprocessing on the device was secured in the reports by reprocessing appropriately in accordance with instructions for use (ifu/cleaning/disinfection/sterilization).It was confirmed that the section of the device with the foreign material residue had no deformation.There was no report that the device was used for procedure while the event occurred.The suggested events can be detected and prevented by handling the device in accordance with the following instructions for use (ifu): 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).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): 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: 18345063
• Report Number: 9610595-2023-19733
• Device Sequence Number: 17525692
• Product Code: FDS
• UDI-Device Identifier: 04953170307515
• UDI-Public: 04953170307515
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

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: 11/27/2023
• 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: 12/18/2023
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2014
• 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