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

Model Number	MAJ-2117
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.
Event or Problem Description
The customer reported that his olympus connecting tubes were breaking during reprocessing.According to the initial reporter, the connector¿s right and left legs were falling off.There was no patient involvement during this event.For reference to related events, please see reports with the following patient identifiers: (b)(6), (b)(6), (b)(6), (b)(6), (b0(6), (b)(6), (b)(6), (b)(6).
Additional Manufacturer Narrative
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, and because the device was not received for evaluation, the definitive root cause of the broken connecting tube could not be determined.It is possible that foreign material was caught between the connection, or that external stress was applied to the tube which broke the lock lever and caused the user to apply force toward the incorrect direction.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿visually inspect the connecting tube to ensure that there are no cracks, breaks, rips, scratches, attached debris, or other irregularities.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
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17143537
• Report Number: 9610595-2023-08939
• Device Sequence Number: 7690086
• Product Code: FEB
• UDI-Device Identifier: 04953170404122
• UDI-Public: 04953170404122
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2023

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-2117
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown