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

Model Number	UM-DG20-31R
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that during pre-use inspection, when the customer connected the ultrasonic probe, which had been used about 5 times, to the drive unit (maj-935), the customer was unable to connect it properly, due to the part that being stuck into the drive unit was starting to come off.The doctor replaced it with another product and completed the procedure.No effect on the patient.The device was returned to olympus for evaluation, and the evaluation found that there is leakage of ultrasound medium from insertion tube.This report is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegations was confirmed.The evaluation found the following: the connecting pin of the connecting tube is shaved; there is leakage of ultrasound media; and there is a hole and impression in the apical sheath.The investigation is ongoing.A supplemental report will be submitted upon completion of the 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, a definitive root cause of the observed chipped connecting tube pin issue could not be determined, however, the issue was likely due to the connection tube being inserted and removed while rotating from the drive unit, resulting in stress being applied to the connecting pin, leading to damage.Additionally, a definitive root cause of the ultrasonic medium leakage could not be determined, however, the issue was likely due to stress applied to the tip sheath, resulting in a hole in the tip sheath and leakage of ultrasonic medium.The event may be detected/prevented by following the instructions for use section below: instruction manual ultrasonic probe set for 3d scanning um-dg20-31r_chapter 3 preparation and inspection_3.4 connection of ultrasonic probe for 3d scanning and related equipment.¿um-dg20-31r connecting pin may be damaged if the connecting part is inserted while rotating prior to hitting the probe driving unit¿.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: 18046988
• Report Number: 3002808148-2023-12095
• Device Sequence Number: 15464252
• Product Code: FET
• UDI-Device Identifier: 04953170368462
• UDI-Public: 04953170368462
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2023

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-DG20-31R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• 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: 10/31/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MAJ-935-PROBE DRIVING UNIT
• Patient Sex: Unknown