MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ULTRASOUND CABLE

Model Number	MAJ-2056
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device evaluation 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 ion robotic bronchoscopy with endobronchial ultrasound with cone beam, (bronchoscopy with biopsy/ flexible bronchoscopy), the sleeve around the ultrasound cable, was worn off completely and the wiring was visible (poor appearance).The procedure was completed with another similar device and procedure delayed by 45 minutes and so was patient¿s anesthesia.There was no adverse impact to the patient.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information, based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide correction to the initial with information inadvertently left out (g2), and an update to field (b1 and h3).The device was evaluated by olympus.And no reportable malfunctions were found, that could have led to the reported event.However, it was discovered, that the a non-reportable malfunction (internal component of the scope connector is exposed) could have led to the reported phenomenon.And the investigation was conducted.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, it was confirmed, that the scope connector cover of the scope connector was removed.Therefore, it is likely, that the removal of the scope connector cover of the scope connector caused an event, that exposed the internal components of the scope connector.Leading to equipment replacement.However, the root cause of the reported event could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: ULTRASOUND CABLE
• Common Device Name: ULTRASOUND CABLE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19656297
• Report Number: 3002808148-2024-06008
• Device Sequence Number: 12491180
• Product Code: IYN
• UDI-Device Identifier: 04953170355677
• UDI-Public: 04953170355677
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K203128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2024

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-2056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• 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: 06/11/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 07/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown