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

Model Number	MAJ-1513
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: complete name: (b)(6) hospital.This report is related to the following linked patient identifier: (b)(6).The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during a diagnostic procedure, a rubber -like object attached to the forceps port of the connecting tube had fallen off into the patient.The rubber from the cleaning tube has been retrieved.It is believed that the rubber broke off when cleaning with a cleaning device made by another company.The rubber broke off and entered the endoscope, causing it to fall off during the examination.The fragments were retrieved using the same device, and the procedure was completed (with the same device).No reports of health hazard.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's (lm) investigation.The subject device was evaluated by olympus, and the following was noted: the device was attached with non-olympus connectors and rubber.Therefore, it was confirmed that the device did not meet its specifications or function.Moreover, the user reported using a non-olympus oer to conduct reprocessing.Therefore, it could not be confirmed if the user deviated from the reprocessing methods outlined in the instructions for use (ifu).The device history record was unable to be reviewed for this device since the serial and/or lot 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 was determined that the foreign material was rubber from the modified subject device (maj-1513).However, the root cause of the reported event could not be identified.The event can be detected/prevented by following the ifu which states: operation manual: ¿do not make inappropriate repairs or modifications." "do not disassemble or modify the product under any circumstances.Doing so may not only cause injury to human body or damage to the product but may also result in a loss of functionality.If the product was required to repair, follow ¿chapter 8: troubleshooting and repair¿.If you are unable to resolve the issue, discontinue use and send the product to olympus for repair.¿ 5 instrument compatibility: ¿this product is compatible with the olympus endoscope reprocessor and olympus endoscopes.To confirm the compatible endoscopes, refer to the separate ¿list of compatible endoscopes/connecting tubes¿ supplied with the olympus endoscope reprocessor or if necessary, contact customer service center, service center designated by olympus, our branch, or sales agency." "compatible endoscope reprocessor: oer-3, oer-4, oer-5, oer-s¿ this supplemental report includes additional information received from the customer.The information has been added to b5.Also, an update has been made to d8, d9 and h3 from the initial medwatch.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was further reported that the broken device fell off and into the patient¿s lung.Although it was confirmed that it was removed, the method of retrieval is reportedly unknown.No additional medical interventions were required.There was no patient harm.

• 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: 20225004
• Report Number: 9610595-2024-18397
• Device Sequence Number: 3365288
• Product Code: FEB
• UDI-Device Identifier: 04953170234026
• UDI-Public: 04953170234026
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAJ-1513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 07/06/2025
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BRONCHOVIDEOSCOPE, BF-F260, SN (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown