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

Model Number GIF-H190

Device Problems Mechanical Problem (1384); Failure to Clean Adequately (4048)

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

Event Date 10/31/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation and the customers allegation was confirmed.It was noted that water tightness was lost due to damage on the channel tube.It was also noted that the air/water cylinder and scope cylinder had no color.The scope cover unit had discoloration and label of the scope connector was damaged.The label on the scope connector was peeled and the insulation resistance at the distal end did not meet standard value due to chip plastic distal cover.The play of up/down knob and bending angles in the up/down/left directions did not meet standard value due to wear of angle wire.The bending section could not be controlled at all due to wear of the angle wire and the adhesive on the bending section rubber was detached.The connecting tube had a wrinkle and the universal cord coating was peeling.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.

Event Description

It was reported to olympus, that the evis exera iii gastrointestinal videoscope had leaking in the distal end.Inspection and testing of the returned device found that there was foreign material between plastic distal end and nozzle.It was also noted that the angle wire was worn and the bending return angle was not possible to achieve.There was no patient harm or user injury reported.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.

Manufacturer Narrative

Correction to h6 (problem code): "4048 - failure to clean adequately" should not be selected on the initial.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 could not be conclusively determined.It is likely water invaded the scope from the bending section while the user was handling the device, which led to increased friction resistance, and as a result caused the angle wire to become worn.This event can be detected by handling the device in accordance with the following instructions for use (ifu): "-inspection of the bending mechanisms".This event can be prevented by handling the device in accordance with the following ifu: "-leakage testing of the endoscope".Olympus will continue to monitor field performance for this device.

Event Description

This mdr is being submitted to capture the only reportable malfunction found during the device evaluation, bending section would not return to neutral due to a worn angle wire.

• 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: 18194966
• MDR Text Key: 329120514
• Report Number: 9610595-2023-17973
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• 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: 11/07/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2018
• 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