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

Model Number	MAJ-2118
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	09/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the connecting tube was falling off apart on the oer-elite reprocessor.The issue was found during reprocessing.There were no reports of patient harm.This medical device report (mdr) is related to patient identifier (b)(6) (maj-2118, 2 of 2).
Additional Manufacturer Narrative
The subject device was manufactured on november, 2020, but the specific date is unknown at this time.The device was returned to olympus and inspected.Visual inspection as received condition confirmed one of the lock levers missing from the air/water connecting tube and its blue connector had a small dent on the edge, but the pins of the reprocessor side connector were intact.Both reprocessor side connectors could go straight into the light blue connectors on olympus test oer-elite until the lock levers were securely engaged.The blue connectors could be attached or detached from the reprocessor properly.The scope side connector was also inspected and found some scratches and white foreign substance on its slide adapter section.However, no moisture stains found inside the connecting tubes.The scope side connector could be attached to or detached from the a/w and suction cylinders of our test ultrasound gastrovideoscope gf-uct180 without a problem.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
This report is being submitted to correct b5 of the initial report.The aforementioned related patient identifier [(b)(6) (maj-2118, 2 of 2)] was found to be a duplicate.There is only 1 event associated with this reportable malfunction.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record could not be performed since the manufacturing date is unknown.Based on the results of the investigation, it is likely that external stress was applied to lock lever of connecting tube, which broke the lever and the tube was unable to be connected.As a cause of external stress, the user may have applied force toward incorrect direction.The event can be prevented by following the instructions for use: "preparation and inspection 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: 16795483
• Report Number: 9610595-2023-06597
• Device Sequence Number: 11548056
• Product Code: FEB
• UDI-Device Identifier: 04953170404139
• UDI-Public: 04953170404139
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2023

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-2118
• Device Lot Number: 0YA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 04/21/2023; 05/23/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 04/28/2023; 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2020
• 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