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

Model Number	MAJ-2138
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported to olympus, the connecting tube clips broke off of all the connectors.The issue was found during reprocessing.The washer was moved to a sister facility.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was not yet returned to olympus for evaluation, but it is expected to return.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device return information.Updated fields: d9, h3.Investigation: one device sample was returned for evaluation.During visual inspection, the reported issue was confirmed; the connecting tube was broken off and could not be re-connected.The lot number information was not provided; without this information, the relevant device history record could not be reviewed.The device instructions for use document was reviewed.Review showed the following relevant instruction for detection of this issue in chapter 9- preparation and inspection: " 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.".The investigation determined that the issue could have been caused by application of force in the incorrect direction.However, the root cause was not definitely established.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: 18044601
• Report Number: 9610595-2023-16261
• Device Sequence Number: 7468555
• Product Code: FEB
• UDI-Device Identifier: 04953170404184
• UDI-Public: 04953170404184
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

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-2138
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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