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

Model Number UM-S20-17S

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/23/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc confirmed the subject device and found that the reported phenomenon was duplicated.When it was operated according to the instruction manual, there were no abnormalities other than foreign material.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during the inspection, the user found that the black foreign material adhering to the inside of the transparent part of distal end of the subject device.The ultrasound image of the subject device was displayed normally.Other detailed information was not provided.There was no report of patient injury associated with the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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.Based on the results of the investigation, it is likely that material has invaded the inside because a hole was formed in the tip sheath.Additionally since indentations were found on the tip sheath and a twist was generated at the sheath location, an external force was applied to the tip sheath while the internal blade was being driven, so the internal blade could not be driven normally and the sheath was opened.The sheath of the insertion part is twisted, the internal blade cannot be driven normally, and an ultrasonic image is not obtained.A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): "ultrasonic probe for endoscope um-s20-17s chapter 4 usage 4.2 observation of ultrasound images ¿ do not push or pull the ultrasonic probe with strong force while the ultrasonic probe is driven (freeze release state), or pull it into the curved part of the endoscope.Slowly push and pull the ultrasonic probe, especially when the endoscope is strongly curved or when the forceps are raised.Pushing and pulling with strong force or sudden movement may cause image distortion or damage to the ultrasonic probe.¿ when driving the ultrasonic probe, return the endoscope to the curvature and forceps as much as possible.Driving with a harsh probe shape may result in image distortion or damage to the ultrasonic probe." olympus will continue to monitor the field performance of this device.

• 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: 13275220
• MDR Text Key: 283969868
• Report Number: 8010047-2022-01558
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/13/2022

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 Model Number: UM-S20-17S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/24/2021
• Initial Date FDA Received: 01/18/2022
• Supplement Dates Manufacturer Received: 03/16/2022
• Supplement Dates FDA Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1