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

Model Number	MAJ-1503
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that while cleaning the gastrointestinal videoscope with the endoscope reprocessor, the endoscope reprocessor started making strange noises.After a while, it was noticed that the cleaning tube near the connector on the washer side was cut.Therefore, the endoscope may have been insufficiently cleaned.It was unclear when the irrigation tube broke, so there was a possibility that multiple endoscopes had been insufficiently cleaned.The issue was found during reprocessing.There were no reports of patient harm or impact associated with this event.This report is related to the following linked patient identifiers:(b)(6).
Additional Manufacturer Narrative
E - initial reporter: (b)(6) hospital.To date, the device has not been returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and customer-provided information.When the issue was reported, olympus requested additional information from the customer on their reprocessing practices.The customer reported these devices are pre-cleaned after procedures with no delay: devices are wiped, suctioned and air/water channel is cleaned using a cleaning adaptor.The customer reported that manual cleaning is performed with olympus endofresh s solution and boston scientific hedgehog brushes.Finally, the devices are disinfected using an olympus oer-5 with acecide 6% disinfectant solution.The customer could not confirm the cleaning tubes are checked as part of the inspection.However, the customer reported the tube had cracked near the base of the connector and torn with only a single strand of the tube connecting with the endoscope, stating the damage would be obvious during connection with the scope prior to reprocessing.The lot number information was not provided in this case; no device history record review could be performed.The device instructions for use document was reviewed.The review showed information relevant to preventing the reported issue under the section preparation and inspection: "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." the investigation determined the reported issue possibly occurred due to stress applied during connection with scope and contact with a sharp object.However, no device sample was provided for analysis and no device photographs were available.The root cause could not be specified.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: 18485765
• Report Number: 9610595-2024-00622
• Device Sequence Number: 2722633
• Product Code: FEB
• UDI-Device Identifier: 04953170233951
• UDI-Public: 04953170233951
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/26/2024

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-1503
• 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: 12/17/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 01/26/2024
• 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: GIF-H190N GASTROINTESTINAL VIDEOSCOPE (SN.(B)(6)).; GIF-H190N(GASTROINTESTINAL VIDEOSCOPE )SN.(B)(6).; OER-5 (SN.(B)(6)).
• Patient Sex: Unknown