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

Model Number	UM-S20-17S
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was received and evaluated.Visual inspection of the device appearance, it was confirmed by hand that the upper part of the probe was broken.Furthermore, device evaluation found image was not displayed, leakage and breakage of device insertion tube was observed.The customer reported issue was confirmed.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
It was reported that during examination ( unspecified procedure) with a bronchoscope, the ultrasound image was not displayed from the beginning of the examination, and the image was not displayed even after multiple replacements.The intended procedure was completed using a similar device with no patient harm or injury reported due to the event.No user injury reported.Device return evaluation found image was not displayed, damage, leakage in the insertion tube was observed.This report being submitted due to the finding of damage, leakage in insertion tube identified during the device evaluation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation and correction to h4.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 root cause of the no image was the ultrasonic image could not be rendered normally because the ultrasonic medium inside the sheath leaked out due to the occurrence of a hole in the sheath at the tip.The ultrasonic wave could not be transmitted normally.Olympus will continue to monitor field performance for this device.

• Brand Name: ULTRASONIC PROBE
• Common Device Name: 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17115525
• Report Number: 3002808148-2023-05881
• Device Sequence Number: 6593704
• Product Code: ITX
• UDI-Device Identifier: 04953170241000
• UDI-Public: 04953170241000
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K982323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2023

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: UM-S20-17S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2023
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BRONCHOSCOPE.; MAJ-1720 (PROBE DRIVING UNIT).NO.7400421.
• Patient Sex: Unknown