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

Model Number OER-5

Device Problem Device Reprocessing Problem (1091)

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

Event Type  malfunction  

Manufacturer Narrative

The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported the endoscope reprocessor was not cleaned properly.The issue was observed during reprocessing and there were no reports patient harm or involvement.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected field e1 (added full name of the facility "(b)(6) hospital".) a review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over three (3) years since the subject device was manufactured.The device was not returned to olympus.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that the user did not thoroughly read the instruction manual, and reprocessing had been performed without attaching to a connecting tube.The event can be prevented by following the instructions for use which state: instructions for oer-5, oeration manual section 4.7 ¿connecting tube installation.¿ to find out what connecting tubes can be used, refer to the provided ¿list of compatible endoscopes/connecting tubes ¿.Warning attach all of the connecting tubes specified according to the type of the endoscope.If reprocessing is performed without attaching all of the required connecting tubes, reprocessing may be ineffective.Although the ¿list of compatible endoscopes/connecting tubes ¿ shows the applicable connecting tubes for each endoscope, it may not list the latest endoscope models.If your endoscope model is not listed, contact olympus for more information.Olympus will continue to monitor field performance for this device.

Event Description

The intended procedure was completed using the same set of equipment.

• 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 (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: 19041444
• MDR Text Key: 339588016
• Report Number: 9610595-2024-07026
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

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: OER-5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2020
• 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
• Treatment: JF-260V/(B)(6); OER-5/(B)(6); OER-5/(B)(6)