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

Model Number	MAJ-2114
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation where the user¿s complaint was not confirmed.A visual inspection was performed, finding both lock levers and metal clips still attached to the (blue) plastic reprocessor connector.Olympus was unable to find any issues connecting the (blue) plastic connector tube device onto the a1 ports of the oer-elite reprocessor.Olympus connected and disconnected the connecting tube (blue) plastic connector multiple times on the a1 ports of the oer-elite reprocessor and no signs of the lock levers/metal clips and (blue) plastic connector coming off/popping off/coming apart.The click sound was verified and secured when connecting the blue plastic connector to the a1 port as well.There were minor scratches on the plastic (blue) connector and on the metal connector.There were minor scratches also noted on the plastic tube outside.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The customer reported to olympus that the connecting tube cannot be connected to the channel connector in the reprocessing bin.There is a metal clip in the clasps that falls off, causing the plastic ¿wings¿ to come off the connector.The reported problem was found during use.There was no harm or user injury reported due to the event.There were no reports of patient harm associated with this event.
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 was unable to be performed due to the exact manufacturing date being unknown.The device was manufactured on an unknown day in february 2021 based of the 3 digit lot number.Based on the results of the investigation, it is likely that the event occurred due to the user not pushing the connecting tube into the connector until it clicks, or, the connecting tube was unable to be connected due to foreign material jamming the tube.The event can be prevented by following the instructions for use (ifu) which state: "ifu for maj-2114 preparation and inspection.Move the lock levers of the reprocessor side connector to make sure that they.Function properly and are not broken.Ifu operation manual for oer-elite chapter 5 inspection and preparation before use inspecting the connectors caution connect each connector firmly by pushing until the connector clicks into place.After connection, pull the connector gently to confirm that it cannot be disconnected easily." 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: lydia sakakeeny ; 800 west park drive; westborough, MA 01581 ; 6177976458
• MDR Report Key: 17033411
• Report Number: 9610595-2023-08226
• Device Sequence Number: 17885848
• Product Code: FEB
• UDI-Device Identifier: 04953170404092
• UDI-Public: 04953170404092
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2023

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-2114
• Device Lot Number: 12A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2023
• 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: 01/20/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 06/20/2023
• 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