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	01/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has been returned to olympus for evaluation.During evaluation, it was observed, one gray clip on the orange connector was broken and detached.The missing gray clip was not returned for evaluation.The pin inside the orange connector had no indications of being bent or damaged.The tubing was examined and there are no signs of punctures, tears, or indications of residue inside the tubing.The metal connectors on the opposite end of the connecting tube had signs of scratches on the housing of the metal connectors.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 technical assistance center (tac), the connecting tube was cracked/broken and could not be connected.There was no harm or user injury reported due to the event.This report is part of a related event.(patient identifier : (b)(6)).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.H4: device manufacturer date: the device was manufactured in january 2021 based on the three-digit lot number.The specific date could not be determined with that information.The device history record (dhr) was unable to be reviewed for this device.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, it is likely the connecting tube could not be connected due to the coming apart of the lock lever by external stress.However, a definitive root cause could not be determined.The following information is stated in the instructions for use (ifu): "9 preparation and inspection 2 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: 16378699
• Report Number: 9610595-2023-02529
• Device Sequence Number: 14927257
• Product Code: FEB
• UDI-Device Identifier: 04953170404184
• UDI-Public: 04953170404184
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 04/11/2023

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-2138
• Device Lot Number: 11A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2021
• 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