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

Model Number	MAJ-2112
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for inspection, and the customer's complaint of broken wing tip was confirmed.Based on the results of the investigation, olympus verified that both lock levers are broken off.The broken portions were not returned for evaluation.The tubing was inspected, and there are no signs of punctures on the tubing or signs of residue inside the tubing.In addition, the device does contain discoloration.It is presumed that external stress was applied to the lock lever of the connecting tube, which broke the lever, and the tube was unable to be connected.As a cause of the external stress above, the user may have applied force toward the incorrect direction.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that during reprocessing the connecting tube was found to be faded and showed a weaking of the plastic with small cracks along the connector and the wing tip was completely broken off.The device was not used during the procedure.There were no reports of patient harm associated with this event.

• Brand Name: CONNECTING TUBE
• Common Device Name: 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21471228
• Report Number: 9610595-2025-80034
• Device Sequence Number: 3492305
• Product Code: FEB
• UDI-Device Identifier: 04953170404078
• UDI-Public: 04953170404078
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K190969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/26/2025

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
• Operator of Device: Health Professional
• Device Model Number: MAJ-2112
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OER-ELITE
• Patient Sex: Unknown