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

Model Number GIF-H190

Device Problems Mechanical Problem (1384); Noise, Audible (3273); Failure to Clean Adequately (4048)

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

Event Date 05/23/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device has been returned to olympus for evaluation.During evaluation, it was observed, blackish liquid was present in the gi tract, black flecks/residue was seen upon inserting a different scope, the scope was noted to be dim, and image was difficult to see, and a leak was found on the air/water channel.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

Olympus received a medsun report medwatch# (b)(4), indicating, during an esophagogastroduodenoscopy (egd) procedure, the physician indicated, the evis exera iii gastrointestinal videoscope had crackling noise sensation.In was also noted, the scope light became dim, and images were difficult to see.Shortly afterwards, it was noted that there appeared to be blackish liquid present in the gastrointestinal (gi) tract, but it was very difficult to see given the quality of the image.Black flecks/residue was seen upon inserting a different scope.During testing of the scope, a leak was found on the air/water channel.During the removal of the air/water channel, the main line was found to be disconnected from the "y" unit of the channel which was noted to be the cause of the leak.There was no harm or user injury reported due to the event.A medsun report has been received and attached in this report.Additional information is being requested regarding the event.

Manufacturer Narrative

The subject device has not been returned to olympus for evaluation.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

Additional information has been received for this event from the customer.The provider contacted the patient and she feels fine.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, correction to the follow up report with information inadvertently left out, and to provide additional data provided through follow-up.Additional data received confirming the user performed last reprocess in accordance with instructions for use.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 phenomenon occurred due to foreign material remained in the air/water channel due to incomplete reprocessing because the channel leaked.Additionally, the phenomenon of the crackling noise from the device could not be identified.The event can be detected/prevented by following the instructions for use which state: " - inspection of the air-feeding function - inspection of the objective lens cleaning function - leakage testing of the endoscope" olympus will continue to monitor field performance for this device.

Manufacturer Narrative

Correction: d3, g1, h10.This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is 9610595.

• 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 965-8 520; JA 965-8520
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 15015124
• MDR Text Key: 304021804
• Report Number: 8010047-2022-11918
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305290
• UDI-Public: 04953170305290
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/15/2024

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
• Device Operator: Health Professional
• Device Model Number: GIF-H190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2022
• Initial Date FDA Received: 07/14/2022
• Supplement Dates Manufacturer Received: 08/16/2022; 05/08/2023; 05/15/2024
• Supplement Dates FDA Received: 09/13/2022; 05/25/2023; 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2015
• 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 Sex: Female