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

Model Number GIF-H185

Device Problems Contamination (1120); Mechanical Problem (1384)

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

Event Date 06/20/2022

Event Type  malfunction  

Event Description

The customer reported that, during a colonoscopy procedure, the suction valve on the subject device broke when trying to remove it and there was no way to remove it from the endoscope.The clips were broken.This occurred at the end of the procedure and the subject device was used to complete the procedure.There was no effect on the patient due to the event.The subject device was sent to an olympus service center for evaluation.During inspection and testing, broken material was found partially blocking the channel.This report is being submitted for the malfunction found during evaluation (material blocking channel).

Manufacturer Narrative

During inspection and testing, broken material was found partially blocking the channel.Visual inspection of the suction cylinder found scratches which confirmed the accessory did not fit properly without effort and broke, part of which was stuck in the suction cylinder and could not be removed.This resulted in the suction function not working.In addition, the adhesive on the bending section cover was separated and worn due to chemical/physical stress, the light guide rod lenses were cracked due to handling, the universal cord was wrinkled due to handling, and angulation did not meet standard value due to elongation of the angle wires.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

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, it was confirmed that an unidentified endoscope accessory broke in the suction cylinder, partially closing the channel.It is likely that the endoscope accessory received excessive force and was damaged could not be removed from the endoscope.The event can be detected by following by inspecting the endoscope which is found in the instructions for use.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III 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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15762035
• MDR Text Key: 307882073
• Report Number: 9610595-2022-03738
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

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
• Device Operator: Health Professional
• Device Model Number: GIF-H185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 11/09/2022
• Supplement Dates Manufacturer Received: 11/15/2022
• Supplement Dates FDA Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2016
• 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