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

Model Number GIF-HQ190

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/31/2024

Event Type  Injury  

Event Description

It was reported the gastrointestinal video scope could not function to the satisfaction of the physician while the patient was anesthetized on the table when the issue occurred.The intended diagnostic gastroscopy procedure was completed using the similar device.Reportedly, additional sedation with propofol were required to complete the procedure.The procedure was delayed for additional 33 minutes.No reports of patient harm.The device was inspected prior to use.

Manufacturer Narrative

The device was returned and the evaluation found that the biopsy channel is leaking.Angle knobs not locking correctly.Angulation has slack.Labels are peeled/damaged.Distal end insulation test has failed.Light guide lens is chipped /cracked.Distal end cap is worn.Bending angle does not meet specification.Bending rubber adhesive is detached.Should additional relevant information become available, a supplemental report will be submitted.

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, it is likely the suggested event "procedure was delayed by wear of a-wire and deformation of ud angulation control knob" occurred due to while the user was handling the subject device, the biopsy channel leaked.The leak led to the falling away of anti-friction agent in the device, subsequently, the angulation wire was worn.Additionally, the up/down angulation control knob was deformed by physical stress.Although the angulation wire and deformation of the up/down angulation control knobs are both non-reportable (non-pae) defects, the deformation could have caused insufficient angulation, resulting in delay of the procedure.However, the specific root cause of the suggested event could not be identified.The event can be detected and/or prevented by following the instructions for use which state: -inspection of the bending mechanisms."do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient." -leakage testing of the endoscope.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 (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: 18707298
• MDR Text Key: 335404653
• Report Number: 9610595-2024-03204
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-HQ190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2020
• 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
• Patient Outcome(s): Other