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

Model Number GIF-H190

Device Problem Mechanical Problem (1384)

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

Event Date 10/26/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation, and the customers allegation was confirmed due to deformation of the universal cord and damage on the channel tube.In addition to the findings in b5, evaluation found the following: due to burn on the plastic distal end cover insulation resistance value at distal end did not meet the standard value and it was discolored, due to wear of angle wire the play of up / down knob was out of the standard value, due to wear of angle wire the play of right/ left knob was out of the standard value, due to wear of angle wire bending angle in up/down/ left direction did not meet the standard value, the grip has discoloration, connector has corrosion, adhesive on the bending section cover was detached, light guide lens had discoloration, plug unit was deformed, air water and the suction cylinder both had no color, and the scope connector cover had discoloration.This event is under investigation.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported the gastrointestinal videoscope was leaking.There was no report of patient harm, injury or procedural delay.The device was returned for evaluation.Evaluation found the angle wire was worn and bending return angle was not possible to achieve.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

Updated: h10 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 observed bending section angulation issue could not be determined, however, the issue was likely due to an ingress of water into the insertion tube due to wear and tear, resulting in corrosion of the bending section wire and coil.The event may be detected by following the instructions for use which states: chapter 5 troubleshooting chapter 3, preparation and inspection, do not use the endoscope and solve the problem as described in section 5.2, troubleshooting guide.If the problem still cannot be resolved, send the endoscope to olympus for repair as described in section 5.4, returning the endoscope for repair.Also, should any irregularity be observed while using the endoscope, stop using it immediately and withdraw the endoscope from the patient as described in section 5.3, withdrawal of the endoscope with an irregularity.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: 18161696
• MDR Text Key: 329340100
• Report Number: 9610595-2023-17582
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305290
• UDI-Public: 04953170305290
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2021
• 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