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

Model Number	MAJ-2330
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the connecting tube cannot be connected to the channel connector in the reprocessing basin.The customer stated the connectors are falling apart.There was a metal clip in the clasps that falls off, causing the plastic ¿wings¿ to come off the connector.There was no patient harm associated with the event.The medical device report (mdr) is related to the following patient identifiers: (b)(6).
Additional Manufacturer Narrative
H10: the subject device was manufactured on december, 2020 based on the provided 3 digit lot information.Therefore 01dec2020 was selected.If full information becomes available, the manufacturer date will be updated.The device was returned to olympus for evaluation and the customer's allegation was not confirmed.The device evaluation was unable to find any issues with connecting the (orange) plastic connector connecting tube device onto the d1 ports of the oer-elite reprocessor.In addition, there were no signs of the lock levers/metal clips and (orange) plastic connector coming off/popping off/coming apart.The click sound was verified and secured when connecting the orange plastic connector to the d1 port as well.The following findings were observed, however are considered non-critical and therefore do not present a potential for harm: there were scratches noted on the (orange) plastic connector, (white) plastic connector and also scratches on the plastic tube outside.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.A review of the device history record could not be performed due to the exact manufacturing date being unknown.Based on the results of the investigation, it is likely that the tube was not pushed enough (until it clicked) during connection, or, foreign material or the like got caught between the connecting part, which made the tube unable to be connected.The event can be prevented by following the instructions for use which state: "ifu for maj-2330 - 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 5.6 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: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17013281
• Report Number: 9610595-2023-08122
• Device Sequence Number: 7637104
• Product Code: FEB
• UDI-Device Identifier: 04953170404207
• UDI-Public: 04953170404207
• 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
• 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-2330
• Device Lot Number: 0ZA
• 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: 05/26/2023
• Supplement Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OER ELITE.
• Patient Sex: Unknown