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

Model Number	MAJ-2112
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the suction connector and the auxiliary water connector were broken for no reason.Consequently, there was cancellation of all procedures on because the facility could not reprocess the scopes.The issue occurred during reprocessing with no evidence of direct patient involvement.Though procedures were cancelled, there was no indication that these were being done urgently or emergently for life-threatening reasons or that the cancellation of said procedures caused any life-threatening complications or health conditions.At this time, there is no evidence that a life-threatening event occurred, that a patient has developed a permanent disability or permanent damage that caused substantial disruption in their ability to conduct normal life functions, or that additional medical or surgical intervention was required to preclude permanent impairment of a body function or damage to a body structure that is suspected to be due to the use of the olympus device.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The following fields have been updated: h6.The device history record was unable to be reviewed for this device since the lot 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 malfunction likely occurred due the connecting tube being broken by external stress applied to lock lever of the tube, which made it impossible for the tube to be connected.External stress on the connecting tube may have been caused by applying force in the wrong direction.Since the device was not returned to olympus for evaluation, the event could not be confirmed and a definite root cause could not be determined.The events can be detected and prevented in accordance with the following sections of the instructions for use: "9 preparation and inspection: 1 visually inspect the connecting tube to ensure that there are no cracks, breaks, rips, scratches, attached debris, or other irregularities.3 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 the field performance of 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: 20517425
• Report Number: 9610595-2024-21743
• Device Sequence Number: 7765199
• Product Code: FEB
• UDI-Device Identifier: 04953170404078
• UDI-Public: 04953170404078
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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
• Operator of Device: Health Professional
• Device Model Number: MAJ-2112
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 10/07/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 11/12/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown