MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. CONNECTING TUBE; ENDOSCOPE REPROCESSOR ACCESSORIES

Model Number MAJ-2110

Device Problem Break (1069)

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

Event Date 03/19/2024

Event Type  malfunction  

Event Description

It was reported the connecting tube had broken connectors.The issue occurred during unknown event.There were no reports of patient harm.

Manufacturer Narrative

To date, the customer have not returned the device for evaluation.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide correction to the initial with information inadvertently left out (b5, d10, e2, e3, and g2) and to provide a correction to the initial (d9).The device was evaluated by olympus and confirmed the result of the reported event.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, it is likely that the suggested event occurred due to external stress, the user could have applied force toward incorrect direction.Additionally, olympus measured fluid pressure of the reprocessor, though it was within the standard value, the pressure was higher than normal.Therefore, we presumed that load applied to the connecting tube was high, which caused connecting tube to be broken.Furthermore, olympus measured fluid pressure of the reprocessor, though it was within the standard value, the pressure was higher than normal.Therefore, we presumed that load applied to the connecting tube was high, which caused connecting tube to be broken.The root cause of the suggested event could not be identified.The event can be detected/prevented by following the instructions for use which state: 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.Additionally, olympus recommended the need to maintain temperatures ideally between 65-70 degrees to prevent further complications, particularly during warmer seasons.Olympus will continue to monitor field performance for this device.

Event Description

It was reported that the event was found during reprocessing.The procedure was a colonoscopy/egd that was both therapeutic and diagnostic.There was no delay in the procedure due to the customer having plenty of endoscopes.The procedures were able to be completed but this reprocessor could only wash one scope at a time.The same device was used to complete the procedure and the device malfunction occurred at the beginning of the procedure.

• Brand Name: CONNECTING TUBE
• Type of Device: ENDOSCOPE REPROCESSOR ACCESSORIES
• 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: 19124532
• MDR Text Key: 341017006
• Report Number: 9610595-2024-08024
• 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: K190969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/27/2024

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/17/2024
• Supplement Dates Manufacturer Received: 05/24/2024
• Supplement Dates FDA Received: 05/27/2024
• 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
• Treatment: OER-ELITE.