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

Model Number UM-S20-17S

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

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

Event Date 04/06/2022

Event Type  malfunction  

Manufacturer Narrative

During inspection and testing, the tip sheath was found to be perforated and ultrasound media was leaking.The reported event (noisy image) was confirmed.The insertion part was not damaged by twisting, fusing, etc.And there was no damage to the ultrasonic probe.A review of the device history record found no deviations that could have caused or contributed to the perforation and leakage.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, since some external force was applied to the tip sheath and a hole was generated, it is presumed that the ultrasonic wave could not be transmitted normally because the ultrasonic medium leaked out from the hole, and that the ultrasonic image was unclear.However, a definitive root cause of the reported issue could not be identified.The device's instruction manual provides the following cautions, which may help to prevent the issue: "freeze the image whenever you are not actively viewing the ¿live¿ ultrasound image.When the equipment is in the freeze mode, no ultrasonic waves are emitted into the patient." "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.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.

Event Description

The customer reported that, while using the radial probe during a radial endobronchial ultrasound procedure, there was visual interference (noise).The user has experience using the device from her previous practice and has not experienced this before.The nose affected the user's ability to detect the anomalies in the procedure.Another similar device was tried with the same result.The procedure was completed and there was no effect on the patient due to the event.The subject device was sent to olympus for evaluation.During inspection and testing, the tip sheath was found to be perforated and ultrasound media was leaking.This report is being submitted for the malfunction found during evaluation (leakage of ultrasound medium).

• 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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15432715
• MDR Text Key: 306358133
• Report Number: 3002808148-2022-02080
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• 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: 04/14/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1