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

Model Number	UM-S20-17S
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported with "tip is not on the probe".Tip fell off.No harm was reported.No patient harm, no user injury reported.
Additional Manufacturer Narrative
In communication with technical assistance center (tac) support engineer, the customer during the call, wanted to know if performing an x-ray could locate the missing tip of the ultrasound probe.Customer was unsure if the device was damaged or not and does not know where the broken tip was or even if it was truly damaged.Tac advised customer to quarantine the device and not use the device.In addition, it was noted that there was no pre check inspection performed on the device prior to use.Customer was advised to send in the device for evaluation however, declined a return material authorization (rma), and indicated that will do so at the later time.Picture of the device however, was provided to tac.In evaluating the photo provided, tac noted that the ultrasound probe was indeed damaged.It was severely damaged that the fluid that bathes the transducer was also missing and appeared soiled.In a follow up communication with the customer, the following information conveyed: the procedure performed was ion bronchoscopy - therapeutic.The missing tip found to be missing during reprocessing.Not sure if the tip was already missing during the case.No x-ray performed on the patient.No injury on the patient, discharged weeks ago (did not provided specific date/time).The issue in addition was escalated to the facility's risk management team, per the pulmonologist, nothing to be concerned about.No further information provided.Customer stated the device was returned to olympus, however, no rma/tracking provided.To date, the subject device has not yet been received for evaluation.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 specific cause of phenomenon could not be identified.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: 16281952
• Report Number: 3002808148-2023-00989
• Device Sequence Number: 20144185
• Product Code: ITX
• UDI-Device Identifier: 04953170241000
• UDI-Public: 04953170241000
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2023

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?: 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: 01/06/2023
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2022
• 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
• Patient Sex: Unknown