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

Model Number	UM-G20-29R
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the device has not been returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus that the tip of the ultrasonic probe was caught in the guide wire and fell off into the patient's duodenum during a diagnostic intraductal ultrasonography.The procedure was completed with the device, and at the physician's discretion, the tip was not collected.The fallen piece can be expected to be expelled from the patient's body.There were no reports of patient injury or any adverse events.There is no evidence that a life-threatening event occurred, that the patient developed permanent damage or impairment, or that additional medical/surgical intervention was done to prevent permanent damage or impairment.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The g2 field was corrected based on information available at the time of the initial submission.The following information was provided by the facility: the doctor at the facility confirmed by endoscopy that foreign body that had dropped out of the body.The facility confirmed that the foreign body was not confirmed to be the one of the ultrasonic probes of subject device.The foreign body may be a product of another company.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's complaint was not confirmed.Based on the results of the investigation, there was no breakage of the tip pf the ultrasonic probe.In addition, the following non-reportable malfunctions were found during the device evaluation: indentations and slight twists on the distal sheath, and the guide wire insertion port was chipped and indented.Also, the ultrasound image was not visualized properly.The malfunctions were due to physical stress applied by the user.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: 17462323
• Report Number: 3002808148-2023-07984
• Device Sequence Number: 7225644
• Product Code: ITX
• UDI-Device Identifier: 04953170078668
• UDI-Public: 04953170078668
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2023

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-G20-29R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/07/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2020
• 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: EU-ME2 PREMIER PLUS, MAJ-1720, LMD-X310S
• Patient Sex: Unknown