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

Model Number	MAJ-2113
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
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
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
Updated fields: d8, e1, e4, h6, and h11.This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The device was not returned to olympus for inspection, and the reportable malfunction was not confirmed.Based on the results of the investigation, it is likely that the connecting tube was broken by external stress applied to lock lever of the tube, which made it impossible for the tube to be connected.However, a definitive root cause for the reported suggested malfunction could not be established.The event can be detected/prevented by following the instructions for use which state: ·labeling: user can detect abnormality by performing the following inspection.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 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: 20513413
• Report Number: 9610595-2024-21679
• Device Sequence Number: 8690235
• Product Code: FEB
• UDI-Device Identifier: 04953170404085
• UDI-Public: 04953170404085
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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-2113
• 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: 11/13/2024
• 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