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

Model Number	MAJ-1904
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In speaking with the olympus technical assistance center (tac), the customer inquired about ordering a connector to use with the connecting tube in the endoscope reprocessor.The customer sent an image of the needle attachment, to which tac informed the customer that the connectors and dilators were not approved to be reprocessed in the endoscope reprocessor.Tac emailed the customer the guide of the compatible connecting tubes for approved use.An olympus endoscopy support specialist (ess) has been dispatched to observe the user facility¿s reprocessing practices from start to finish and provide reprocessing in-service training, if necessary, to correct and address any reprocessing deviations.The device is not expected to be returned for evaluation.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus that an unapproved needle attachment had been used to reprocess the connecting tube.The issue occurred during reprocessing, and there was no patient harm associated with the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.H4: based on the 3 digit lot number provided, the manufacturing date of the device was in the month of september 2022 but a specific date could not be identified.The olympus endoscopy support specialist (ess) reviewed the reprocessing steps with the customer.Additionally, it was reported that the customer is not going to reprocess dilators in the oer-pro as this has not been validated.The device history record was unable to be reviewed for this device, as only the 3 digit lot number was 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¿s likely the unapproved needle attachment was used during reprocessing because the customer deviated from the instructions for use.The root cause of this event was unable to be identified.The event can be detected by following the instructions for use which state: ¿3 instruction manual this instruction manual contains essential information on using this product (maj-1904) safely and effectively.Before use, thoroughly review this manual, the instruction manual for the endoscope reprocessor, and the separate ¿list of compatible endoscopes/connecting tubes¿ supplied with the olympus endoscope reprocessor.¿ 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: 16265634
• Report Number: 9610595-2023-01486
• Device Sequence Number: 17214830
• Product Code: FEB
• UDI-Device Identifier: 04953170299353
• UDI-Public: 04953170299353
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K120357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2023

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-1904
• Device Lot Number: 29A
• Was Device Available for Evaluation?: No
• 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: 01/04/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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