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

Model Number	GIF-H180J
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The olympus endoscopic support specialist (ess) on behalf of the customer reported to olympus, a polyp was sucked up into the trap of the evis exera ii gastrointestinal videoscope.During the procedure a gastro polyp was found, the doctor used a cold snare to remove the polyp.A trap was then placed on the endoscope connector and when the nurse checked the trap for a polyp, the staff noted a thick pink tinged tan / brown frothy substance in the trap (the doctor noted that nothing in the stomach looked similar to the substance seen).No liquid or substance was noted in the patient's stomach or esophagus during the procedure, which concerned the physician.The scope was reprocessed / brushed without incidence, passed leak tests, and the resi-test was negative post pre-cleaning by central sterile supply (css), it was recommended that the scope be sent out to be checked.The issue was found during a therapeutic esophagogastroduodenoscopy (egd), the procedure was completed with the same device, and without delay.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was not confirmed.The device evaluation did not find any foreign material exiting from the channel.Additional findings include the following: the plastic distal end cover and insulation had scratches / cracked glue / dents, the bending section cover adhesive had a crack, the forceps passage had a tear, switch 2 / 3/ 4 had scratches, the insertion tube had a cut on the boot / minor scratches, the control body had missing color rings, the light guide tube had dents / scratches, the scope connector was loose, the right / left / up / down control knob movement was loose, and the production labels were illegible.The investigation is ongoing, a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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.The foreign object was unable to be identified.There was no deviation from the instruction manual in the reprocessing procedure for areas where foreign matter remained.No physical damage was observed where foreign matter remained.The detection method is described in the instruction manual evis exera ii gif/cf/pcf type 180 series operation manual chapter 3 preparation and inspection.Prevention measures are described in the instruction manual 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: 17683247
• Report Number: 9610595-2023-12704
• Device Sequence Number: 2598615
• Product Code: FDS
• UDI-Device Identifier: 04953170275456
• UDI-Public: 04953170275456
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K051645
• 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): 09/28/2023

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-H180J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2023
• 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: 08/09/2023
• Supplement Date Received by Manufacturer: 09/24/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2014
• 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