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

Model Number UM-S20-17S

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The device has been returned to olympus service center for evaluation.The insertion tube was deformed (wrinkles) across the entire probe.There were dents and holes in the distal sheath, and there was leakage of ultrasound medium.There were indentations and holes in the distal sheath.Ultrasound images did not appear properly.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 3 years since the subject device was manufactured.Based on the results of the investigation, it was presumed that the internal blade (flexible shaft) could not be driven normally when an impact was applied to the tip sheath while the internal blade (flexible shaft) was being driven, and twisting occurred in the sheath.It was presumed that an impact was applied to the sheath at the tip, which caused a hole in the sheath at the tip, leading to leakage of the ultrasonic medium.The root cause of the event could not be identified.Olympus will continue to monitor field performance for this device.

Event Description

The customer reported to olympus the insertion tube on the ultrasonic probe was deformed (wrinkles) across the entire probe.The issue was observed during an unspecified procedure.The device had been used 10-20 times.The procedure was completed with a similar device.There were no reports of patient harm or impact associated with this event.Inspection and testing of the returned device revealed breakage of the insertion tube which was attributed to excessive force.This medical device report (mdr) is being submitted to capture the reportable malfunction found during device evaluation.

• 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: 18567963
• MDR Text Key: 333541259
• Report Number: 3002808148-2024-00711
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/23/2024

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
• Device Operator: Health Professional
• Device Model Number: UM-S20-17S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2020
• 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