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

Model Number UM-S20-17S

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Event Description

The customer reported that, during reprocessing, the teflon sheath on the subject device was found to be cracked.It was noted that the probe had been used very little.There was no procedural impact or patient harm associated with the event.The subject device was sent to an olympus service center for evaluation.During inspection and testing, ultrasonic medium was leaking from the insertion tube.This report is being submitted for the malfunction found during evaluation (leakage of ultrasonic medium).

Manufacturer Narrative

During inspection and testing, ultrasonic medium was leaking from a break in the insertion tube.The break point was not flat and did not have a cross section as if cut by a blade but had traces of a kinked break.A review of the device history record found no deviations that could have caused or contributed to the 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 break in the insertion section which was likely caused by the inability for the internal blade (flexible shaft) to be driven properly.As a result, the sheath was threaded resulting in the break.However, a definitive root cause of the reported issue could not be identified.Olympus will continue to monitor field performance for this device.The reported issue (cracked sheath) was confirmed during testing.The sheath was dented due to damage or deformation due to physical stress.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: 15991896
• MDR Text Key: 308152153
• Report Number: 3002808148-2022-05278
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K982323
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UM-S20-17S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2021
• 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