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

Model Number	MAJ-2330
Medical Device Problem Codes	Device Reprocessing Problem (1091); Use of Device Problem (1670); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for inspection; however, an endoscopy support specialist (ess) was dispatched to the customer site and during a demonstration of the connecting tube (maj-2330) attachment on the ultrasound gastrovideoscope (gf-uct180), debris was observed, indicating improper reprocessing.Staff were instructed to repeat cleaning per the instructions for use (ifu) until no visible debris remained on the brush.During the observation, no suction source was utilized for the aspiration step.An incorrect accessory (auxiliary water tube) was attached instead of the required washing tube.The scope was reprocessed in a third-party automated endoscope reprocessor, rather than the olympus endoscope reprocessor (oer-elite), and lacked the proper distal tip attachment.Based on the available information, the issue was most likely attributed to failure to follow the manufacturer¿s instructions for use (ifu).Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was observed during the device inspection at the customer site, that the connecting tube exhibited visible debris.There were no reports of patient involvement.

• 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: 25232904
• Report Number: 9610595-2026-41100
• Device Sequence Number: 13351515
• Product Code: FEB
• UDI-Device Identifier: 04953170404207
• UDI-Public: 04953170404207
• Combination Product (Y/N): N
• Initial Reporter State: NY
• PMA/510(K) Number: K190969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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: Other
• Device Model Number: MAJ-2330
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ULTRASOUND GASTROVIDEOSCOPE (GF-UCT180)
• Patient Sex: Unknown