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

Model Number OER-PRO

Device Problem Mechanical Problem (1384)

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

Event Date 09/05/2022

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer (fse) was dispatched to evaluate and repair the device.The fse observed, the yellow connector was chipped on the outer ring, center pin was intact and there was no disruption of fluid flow through the channel.Fse replaced the yellow connector to resolve the reported issue.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

The customer reported to olympus technical assistance center (tac), the endoscope reprocessor had a broken yellow connector.There was no harm or user injury reported due to the event.

Event Description

There was no patient care or procedure issue.The facility had two reproccessors, and was able to label the affected reproccessor as "not for use/dated".

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Section b5 was updated with additional information about the event.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The cause of the reported event cannot be conclusively determined.Based on the results of the investigation, it is likely the connector could not be connected as some impact was added to the connector and the connector became loose and came apart.Probable causes for the event include: "* accumulated stress over time which caused the connector to get loose * unintentional impact to the connector with something hard." per the instructions for use: ¿check the following for each connector.The connector should be fixed firmly.The o-rings should be free of abnormalities such as cracks, tears, or dents.¿ and ¿warning -do not use the equipment if any connector seems to be damaged or defective.Using the equipment when an irregularity has been detected may interfere with reprocessing.Furthermore, fluid leakage may damage peripheral device or facilities near the equipment.¿ 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: 15538606
• MDR Text Key: 306681205
• Report Number: 9610595-2022-02562
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/03/2022

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-PRO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2022
• Initial Date FDA Received: 10/04/2022
• Supplement Dates Manufacturer Received: 10/05/2022
• Supplement Dates FDA Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2013
• 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