MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. CONNECTING TUBE

Model Number MAJ-2110

Device Problem Crack (1135)

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

Event Date 02/08/2024

Event Type  malfunction  

Manufacturer Narrative

The device was not returned, it was evaluated onsite.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported, that during the device evaluation the scope connector tubing of the endoscope reprocessor was found to be cracked.There were no reports of patient involvement or injury.

Manufacturer Narrative

The initial mdr was submitted under device oer-elite, under report id: 9610595-2024-03560.This medwatch has been submitted with the corrected device as stated in section d.Suspect medical device.

Manufacturer Narrative

Correction: h4 should be blank as a serial or lot number was not provided for the maj-2110.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the root cause of the event was unable to be identified.It is likely that the lock lever of the cleaning tube was damaged due to an external load, making it impossible to connect.An external load on the cleaning tube may be caused by applying force in the wrong direction.The event can be detected/prevented by following the instructions for use which state: "9 preparation and inspection 1, visually inspect the connecting tube to ensure that there are no cracks, breaks, rips, scratches, attached debris, or other irregularities.2, move the lock levers of the reprocessor side connector to make sure that they function properly and are not broken.".Olympus will continue to monitor field performance for this device.

• Brand Name: CONNECTING TUBE
• Type of Device: CONNECTING TUBE
• 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: 18743570
• MDR Text Key: 336200906
• Report Number: 9610595-2024-03560
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170404054
• UDI-Public: 04953170404054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2024

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: MAJ-2110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 02/21/2024; 04/01/2024
• Supplement Dates FDA Received: 03/04/2024; 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2021
• 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