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

Model Number UM-S20-17S

Device Problem Break (1069)

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

Event Date 02/23/2024

Event Type  malfunction  

Event Description

It was reported that the ultrasonic probe broke off during the procedure.No messages were displayed other than the probe started curling fast.The issue occurred during bronchoscopy with endobronchial ultrasound under navigation, which was completed using the same set of equipment.An xray was done to confirm that nothing was left in the patient.There were no reports of procedure extension and patient harm.

Manufacturer Narrative

The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was not returned; therefore, the reported phenomenon or condition of the device could not be confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It was confirmed that the device was shipped according to the specifications.The specific root cause of the reported problem could not be determined at this time.Olympus will continue to monitor field performance for this device.

Event Description

This report is being supplemented based on the legal manufacturer's final investigation.

• 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: 18907301
• MDR Text Key: 337760715
• Report Number: 3002808148-2024-31439
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170241000
• UDI-Public: 04953170241000
• 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: 04/09/2024

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
• Device Operator: Health Professional
• Device Model Number: UM-S20-17S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 03/17/2024
• Supplement Dates FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1