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

Model Number UM-S20-17S

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 06/27/2023

Event Type  malfunction  

Manufacturer Narrative

At this time olympus has not received this device back for testing and evaluation.Should the device be returned, an evaluation will be completed, and a follow up report will be submitted.

Event Description

The customer reported to olympus the ultrasonic probe that holds the catheter contained blood that could not be removed.The reported issue was discovered after an unknown therapeutic procedure during reprocessing (after high level disinfecting) of the scope.There was no patient/user harm or injury reported due to 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.Based on the results of the investigation, the root cause could not be conclusively determined as the device was not returned for evaluation.Multiple attempts were performed to obtain the device, but no response was received from the customer.Based on the available information, it is likely the sheath at the distal end of the probe had perforated due to the user's handling, and blood had invaded inside the sheath through the damaged part during the procedure.The event can be prevented by handling the device in accordance with the following instructions for use (ifu): "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." olympus will continue to monitor field performance for this device.

• 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: 17375007
• MDR Text Key: 320379727
• Report Number: 3002808148-2023-07386
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/11/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 09/07/2023
• Supplement Dates FDA Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2023
• 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