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

Model Number	MAJ-2330
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device manufacturer date: the device was manufactured in july 2012 based on the three-digit lot number.The specific date could not be determined with that information.The suspect device was sent to an olympus service center for evaluation.Inspection and testing confirmed the complaint.One side of the grey lock levers and one side of the metal clips were detached and missing from the plastic connector side.The missing/detached metal clip and lock lever were not returned.A review of the device history record was unable to be reviewed for this device since the manufacturing date could not be determined with the available information.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the legal manufacturer's investigation, it is likely the connecting tube could not be connected due to detachment of the lock lever by external stress.As for the cause of the external stress, the user may have applied force toward the incorrect direction.However, a definitive root cause of the reported issue could not be identified.The device's instruction manual provides the following, which may help to detect the issue: "move the lock levers of the preprocessor side connector to make sure that they function properly and are not broken." olympus will continue to monitor field performance for this device.In addition, there were scratches on the outside of the tube, on the plastic connector, on the teflon connector, and on the connecting lever.Per the legal manufacturer, these device defects have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.
Event or Problem Description
The customer reported the subject device could not be connected to the channel connector in the reprocessing basin.There was no harm or user injury reported due to the 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: 16330254
• Report Number: 9610595-2023-02020
• Device Sequence Number: 6789482
• Product Code: FEB
• UDI-Device Identifier: 04953170404207
• UDI-Public: 04953170404207
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/08/2023

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-2330
• Device Lot Number: 27A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2012
• 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-PRO: OLYMPUS ENDOSCOPE REPROCESSOR
• Patient Sex: Unknown