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

Model Number UM-3R-3

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Date 11/07/2022

Event Type  malfunction  

Event Description

An olympus employee reported on behalf of the customer, the ultrasonic probe ultrasound images are unclear and difficult to see during surgery.The frequency is not high.The procedure was completed using another device.There was no report of patient harm associated with this event.During incoming inspection, it was determined there was leakage in the ultrasonic medium due to perforation in the tip sheath.This medwatch is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegation of unclear images was not confirmed.In addition, there was leakage in the ultrasonic medium due to perforation in the tip sheath.Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information becomes available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the ultrasonic image could not be rendered normally because the ultrasonic wave could not be transmitted normally due to the leakage of the ultrasonic medium inside and the contamination of air bubbles due to the occurrence of a hole in the sheath at the tip due to external force being applied.The event can be detected/prevented by following the instructions for use which state: "5.2.3 check for air bubbles - the ultrasound probe contains an ultrasound medium (liquid).Due to storage conditions, air bubbles may be generated around the ultrasonic probe or there may be no medium at the tip.Before using the ultrasound probe, be sure to check the air bubbles described here.If there is no medium or air bubbles around the ultrasonic probe, remove the air bubbles according to the instructions in "5.2.4 removal of the air bubbles".If there are bubbles on the ultrasonic transducer, a good ultrasonic image cannot be obtained." "5.2.2 inspection of appearance - inspection method: 1.Lightly pinch the probe insert with your finger and check that there are no noticeable breaks or media leaks over the entire length.2.Check the probe connection tube for dirt or foreign matter." olympus will continue to monitor field performance for this device.

Manufacturer Narrative

Updated field: b5 and h10.This report is being supplemented to provide additional information based on the device evaluation.

Event Description

Additional information was provided regarding this event.The intended procedure was a diagnostic ultrasound endoscopy.There was no delay in procedure.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15933607
• MDR Text Key: 308108678
• Report Number: 3002808148-2022-04967
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170063213
• UDI-Public: 04953170063213
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K001203
• 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,Followup,Followup
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UM-3R-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2022
• 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