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

Section e1: establishment name: (b)(6) hospital.It was noted that the site paid close attention to important points such as the condition of the connector pins and the water fountain flowing from the hole to the top cover.The cleaning tube was not inspected for damage.The tube section seemed to split from near the base of the connector, and it looked like it was connected by a single piece of skin, so it would have been obvious if it had been damaged when the endoscope was installed.The device was not returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

It was reported to the distributor, that the endoscope reprocessor made strange noises at a certain point.It was noted that the cleaning tube near the connector on the washer side was cut.It was not known when the irrigation tube broke.The issue was found during reprocessing.There was no patient harm or user injury reported.

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 the results of the investigation it was confirmed the customer reprocessed the device with a torn connecting tube.The specific cause of the torn connecting tube was not established.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu) which states the following: ¿before using the equipment, always check that there is no irregularity regarding the following points on the connecting tubes and leak test air tube.All tubes should be free of cracks, breaks, fissures, scratches, or stains.There should be no cracks in the lock levers of connecting tube connectors.There should be no bends or breaks in the pin of connecting tube connector.The tube should not be easy to disconnect once connected.¿ 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 (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: 18457394
• MDR Text Key: 332388252
• Report Number: 9610595-2024-00349
• 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,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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