MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. ENDOSCOPE REPROCESSOR

Model Number OER-4

Device Problem No Display/Image (1183)

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

Event Date 08/07/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.If additional information becomes available this medical device report will be supplemented accordingly.

Event Description

Olympus (omsc) was informed that during reprocessing there was a problem with the acecide film that prevented it from being set in the automatic endoscope reprocessor.The customer reported problem has been resolved and it is being used.The details are unknown including whether or not an error occurred or how it was corrected.No health hazards occurred.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Corrected operator of device.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 3 years since the subject device was manufactured.The device met all specifications at the time of shipment.Based on the results of the investigation, it is likely that the container was laid on its side during transportation or storage which caused the chemical solution to come into contact with the gas release sheet, making it difficult for the gas generated over time to escape, and the container may expand temporarily.Therefore, there is a possibility that the container has temporarily expanded and part of the tape has stretched, causing the film to get caught and making it impossible to set.In addition to the above bottle expansion, there is a possibility that it occurred due to the combination of various factors such as variations in tape winding work within the range without deviation, variations in container molding, variations in tape looseness inspection, variations in oer-4 tray size and sensor position, etc.However, since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15366531
• MDR Text Key: 305149366
• Report Number: 9610595-2022-01579
• Device Sequence Number: 1
• Product Code: FEB
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2022

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: OER-4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 09/06/2022
• Supplement Dates Manufacturer Received: 09/22/2022
• Supplement Dates FDA Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2019
• 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