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

Model Number	MAJ-1511
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that during reprocessing, the connecting tube was popping off.The connecting tube could not be connected to the channel connector in the reprocessing basin.There were no reports of patient harm associated with this event.Subsequently, the customer reported that the device is not being returned because the problem was resolved.The issue was due to user error.This complaint is related to patient identifier (b)(6) (lf-gp/serial number: unknown).
Additional Manufacturer Narrative
The subject device referenced in this report is currently working correctly and will not be returned for evaluation; therefore, the device evaluation could not be completed.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.
Event or Problem Description
This complaint is related to patient identifier (b)(6) (oer-pro/endoscope reprocessor/serial number: unknown).
Additional Manufacturer Narrative
Updated: d8, h6.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Section g2 was corrected to additionally indicate that the initial reporter is a healthcare professional.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the definitive root cause of the connecting tube was due to user error.It is possible that the tube was not pushed enough until it clicked during connection.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿over time, the connecting tube will deteriorate because it is subject to wear with each use.If any of the following are found with the connecting tube, do not use it and replace it with a new one.Connecting a defective tube could prevent the effectiveness of the cleaning and high-level disinfection process.Move the lock levers of the connecting tube to make sure that they function properly and are not broken.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: 16587933
• Report Number: 9610595-2023-04797
• Device Sequence Number: 6099745
• Product Code: FEB
• UDI-Device Identifier: 04953170234002
• UDI-Public: 04953170234002
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K103264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2023

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-1511
• Device Lot Number: UNKNOWN
• 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: 02/21/2023
• Supplement Date Received by Manufacturer: 03/23/2023; 05/09/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 03/28/2023; 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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-PRO/ENDOSCOPE REPROCESSOR.
• Patient Sex: Unknown