MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III SMALL INTESTINAL VIDEOSCOPE; SMALL INTESTINAL VIDEOSCOPE

Model Number SIF-H190

Device Problem Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found the light guide lens had foreign objects.In addition, the evaluation found the following; the adhesive on the bending section cover had a crack, due to clogging of the nozzle, the water removal ability did not meet the standard value, due to slipping out of the light guide bundle, illumination was poor, the plastic distal end cover had a scratch and the connecting tube had a dent.Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The customer reported to olympus, the evis exera iii small intestinal videoscope had dirt inside the light guide lens.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found; the light guide lens had foreign objects.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during 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.Based on results of the investigation, the reported foreign material on the light guide lens at the distal end could not be identified and a definitive root cause of the issue could not be determined, as there was no observed deformation that might result in the retention of foreign material and no additional facility device reprocessing information was reported or available, however, the issue was likely the result of insufficient device cleaning/reprocessing.The issues may be detected/prevented by following the instructions for use sections below: sif-h190 operation manual chapter 3 preparation and inspection.Sif-h190 reprocessing manual chapter 5 reprocessing the endoscope (and related reprocessing accessories).Reprocessing survey info: - was the device as cleaned, disinfected, and sterilized before being sent to olympus: yes.- was there a delay in the start of pre-cleaning: unknown.- were there abnormalities in the accessories used for reprocessing: not answered.- did the customer flush the air/water nozzle / channel with the detergent solution: yes.- did the customer wiped/brushed the air/water nozzle with clean lint-free cloths, brushes, or sponges: yes.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III SMALL INTESTINAL VIDEOSCOPE
• Type of Device: SMALL INTESTINAL 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: 18232711
• MDR Text Key: 330430301
• Report Number: 9610595-2023-18321
• Device Sequence Number: 1
• Product Code: FDA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SIF-H190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2021
• 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