MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ULTRASONIC PROBE

Model Number UM-S20-17S

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/13/2024

Event Type  Injury  

Manufacturer Narrative

This report has been submitted by the importer under this mdr report number 3002808148-2024-32257.The evaluation of the event is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

It was reported that the radial probe was not working.The issue occurred during super d navigational bronchoscopy procedure.It failed when the radial probe was introduced into the scope.The patient was under anesthesia and physician used alternative procedure.The procedure was completed with regular endobronchial ultrasound.Additional information received that the patient had a solitary lung mass in right lower lobe with malignant neoplasm of salivary gland.Oncology requested for additional tissue samples prior to staging.The patient was sent home in stable condition and was rescheduled later in april for navigational bronchoscopy.There were no reports of patient injury.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved final investigation and to correct b2 and h6 heic.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 radial probe not working was confirmed.The definitive root cause of the radial probe is not working could not be determined.However, the likely cause of the radial probe not working was traced to component failure, which is expected or random component failure without any design or manufacturing issue.The event was classified conservatively as a serious injury as the initial procedure did not go as planned, necessitating an alternative approach and a subsequent procedure.The patient did not suffer harm.Olympus will continue to monitor field performance for this device.

Event Description

It was reported that the radial probe was not working.The issue occurred during super d navigational bronchoscopy procedure.It failed when the radial probe was introduced into the scope.The patient was under anesthesia and physician used alternative procedure.The procedure was completed with regular endobronchial ultrasound.Additional information received that the patient had a solitary lung mass in right lower lobe with malignant neoplasm of salivary gland.Oncology requested for additional tissue samples prior to staging.The patient was sent home in stable condition and was rescheduled later in april for navigational bronchoscopy.There were no reports of patient injury.

• Brand Name: ULTRASONIC PROBE
• Type of Device: ULTRASONIC PROBE
• 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19140063
• MDR Text Key: 340566821
• Report Number: 3002808148-2024-32292
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: UM-S20-17S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/03/2024
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SCOPE
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 76 KG