MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC PROBE

Model Number UM-S20-17S

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/06/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record found no deviations that could have caused or contributed to the reported issue.The reported issue was confirmed during evaluation.No other defects were found.Based on the results of the investigation: the insertion section sheath was twisted off and damaged.Several indentations on the distal end sheath were confirmed.Internal sheath is bent.Given that the broken part seems to have been twisted off, it occurred seemingly because the internal blade was unable to function properly causing the internal sheath got caught in and twisted off.Given that there are several indentations on the distal end sheath, the internal blade of the device could not work properly because external force may have been applied to the device and buffered the blade inside the sheath while it was running.A definitive root cause could not be identified.Per the instructions: never push or pull the ultrasonic probe with excessive force or withdraw it into the bending section of the endoscope during probe rotation (real-time mode).Manipulate the ultrasonic probe slowly and carefully when the endoscope is sharply angled, or the forceps elevator is raised.Forcefully pushing or pulling the ultrasonic probe may damage it.Do not attempt probe rotation while the ultrasonic probe is advanced abruptly.This could result in image flow and impeded or cause irregular rotation.Olympus will continue to monitor field performance for this device.

Event Description

The customer reported to olympus during inspection before use of the device when the freeze of the ultrasonic observation device was released and the ultrasonic probe was driven, the flexible shaft was twisted.The unknown procedure was completed by switching to another model of the same device.During investigation of the returned device and reported event, it was observed the sheath of the insertion section was damaged resulting in leakage of ultrasonic medium.This report is being submitted for the malfunction found during investigation.There was no impact on patient's health.

• Brand Name: ULTRASONIC PROBE
• Type of Device: ULTRASONIC PROBE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14083993
• MDR Text Key: 289083045
• Report Number: 8010047-2022-06116
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K982323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• 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: 02/03/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2020
• 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
• Treatment: EU-ME2 ENDOSCOPIC ULTRASOUND CENTER; MAJ-1720 PROBE DRIVING UNIT