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

Model Number	MAJ-1500
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not been returned to olympus for evaluation.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, during preparation for use, the connecting tube which was using acecide was ¿hardy.¿ it was noted, sample was taken to figure out the reason for this event.There was no harm or user injury reported due to the event.Additional information has been requested regarding this event.If information is received, a supplemental report will be submitted.
Event or Problem Description
The customer stated they used 3m enzyme-detergent 70508e, which is a non-olympus product, with the reported olympus device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, device evaluation, and correction to b5.The device was returned to olympus for evaluation, and the customer's complaint was confirmed.The customer stated the following: the endoscopes are being precleaned immediately after each procedure, the endoscopes are being manually reprocessed prior to reprocessing them, the cleaning detergent/disinfectant solution being used with the endoscopes during manual cleaning: 3m enzyme detergent (product code 70508e), the internal channels of the endoscopes are being brushed, the endoscopes are being leak tested after the manual cleaning and then they disinfect endoscopes.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely that the event occurred due to user handling.The material (organic silicon) may have originated from anti-foaming agent in chemicals.The event can be prevented by following the instructions for use which state: "ifu operation manual for oer-aw chapter 3 inspection before use 3.5 inspecting the remaining quantity of detergent, and preparation warning always use the olympus-designated detergent.If a non-designated detergent is used, the endoscope may not be properly cleaned or the predetermined sterilization effect may not be achieved." 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: 16272165
• Report Number: 9610595-2023-01539
• Device Sequence Number: 15340716
• Product Code: FEB
• UDI-Device Identifier: 04953170233937
• UDI-Public: 04953170233937
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K103264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

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-1500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/06/2023
• Supplement Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 07/06/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown