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

Model Number UM-G20-29R-3

Device Problem Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Event Description

The customer reported that, during preparation for use, the subject device did not drive when connected to the drive unit.The subject device was sent to olympus for evaluation.During inspection and testing, a leak was found.This report is being submitted for the malfunction found during evaluation (leak).There was no harm or user injury reported due to the event.

Manufacturer Narrative

During inspection and testing, the tip sheath was perforated and there was leakage of ultrasonic medium.A review of the device history record found no deviations that could have caused or contributed to ultrasonic medium leaking.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, it is likely the ultrasonic medium leaked due to a hole being generated in the tip sheath because of external force being applied.However, a definitive root cause of the reported issue could not be identified.The device's instruction manual provides the following warning, which may help to prevent the issue: "when pulling the ultrasonic probe out of the endoscope, make sure that the freeze-switch of the observation device is on (freeze-status).Pulling the ultrasonic probe while it is driven may damage the ultrasonic probe." olympus will continue to monitor field performance for this device.The reported issue (not driving) was confirmed during testing.The probe did not drive at all even when connected because there was a twist in the connection cylinder root of the insertion section sheath.Per the legal manufacturer, this device defect has no potential to cause or contribute to death or serious injury if the malfunction were to recur.

• 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: 15882443
• MDR Text Key: 307669877
• Report Number: 3002808148-2022-04690
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170078668
• UDI-Public: 04953170078668
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K001203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UM-G20-29R-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2022
• 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