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

Model Number GIF-H185

Device Problems Device Reprocessing Problem (1091); Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.Device evaluation confirmed that there was instrument channel malfunction, the biopsy channel was found clogged by a plastic material.The reported issue of " broken swab inside " (cleaning brush insertion) issue was confirmed.Service repair has noted that a foreign plastic material likely from cleaning brush and that could not be removed was clogging the biopsy channel.However, at the stage of inspection, it was noticed that it was impossible to remove the clogging material from the channel and therefore the biopsy channel needs to be replaced.Furthermore, the following defects were identified during device inspection: worn out glues on the lenses.Cracked light guide lens.Bending angulations out of specifications.Annual preventive maintenance of keytop 1 rubber required.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

Customer reported with an issue of " broken swab inside " (cleaning brush insertion) issue.No harm was reported.No patient harm, no user injury reported.Device evaluation found foreign material clogged inside the device biopsy channel and cannot be removed due to instrument channel malfunction.This report is being submitted due to the finding of foreign material inside the biopsy channel that cannot be removed (foreign material cannot be removed even if the correct reprocess is performed due to the buckling of each channel, problems related to reprocessing, insufficient reprocessing) identified during device return evaluation.

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.It has been over 6 years since the subject device was manufactured.Based on the results of the investigation, it is likely the biopsy channel clogged by a plastic material occurred due to insufficient or incorrect reprocessing.However, a definitive root cause could not be determined.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: 16444869
• MDR Text Key: 310897536
• Report Number: 9610595-2023-03322
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/05/2023

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: 02/03/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/27/2023
• Supplement Dates Manufacturer Received: 05/17/2023
• Supplement Dates FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2017
• 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