MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. GASTROINTESTINAL VIDEOACOPE; GASTROINTESTINAL VIDEOSCOPE

Model Number	GIF-LV1
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the device evaluation, the gastrointestinal videoscope exhibited foreign material in the nozzle, plastic distal end cover, bending section cover, adhesive around the objective lens, connecting tube, and the up/down/right/left knobs.There were no reports of patient involvement.
Additional Manufacturer Narrative
The device evaluation found foreign material in the nozzle, plastic distal end cover, bending section cover, adhesive around the objective lens, connecting tube, and the up/down/right/left knobs.The legal manufacture reviewed the customer provided the cleaning disinfection and sterilization (cds) processes where the following deviations from instructions for use (ifu) were confirmed: a possible delay in pre-cleaning, a possibility that sufficient brushing could not be performed, and the device was not correctly reprocessed.Based on the results of the investigation, it is likely that reprocessing deviated from the ifu led to the malfunction; however, the type of the material or definitive root cause cannot be identified.A device history review revealed no issues that could have caused or contributed to the reported issue.This issue is addressed in the ifu and reprocessing manual: "all channels of the endoscope, including the instrument channel, and all accessories used with the endoscope during the patient procedure, such as all valves, must be reprocessed after each patient procedure, even if the channels or accessories were not used during the patient procedure.Insufficient reprocess of these components may pose an infection control risk to patients and/or operators." olympus will continue to monitor the field performance of this device.

• Brand Name: GASTROINTESTINAL VIDEOACOPE
• 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19038358
• Report Number: 9610595-2024-06992
• Device Sequence Number: 8168000
• Product Code: FDS
• UDI-Device Identifier: 04953170312373
• UDI-Public: 04953170312373
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K111756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2024

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: Other
• Device Model Number: GIF-LV1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2017
• 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