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

Model Number UM-S20-17S

Device Problem Mechanical Problem (1384)

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

Event Date 01/10/2023

Event Type  malfunction  

Event Description

The end user facility contacted olympus to report that, when in use in conjunction with a evis lucera elite bronchovideoscope, the ultrasonic probe could not be removed.An exam had been completed, with both the probe and scope being removed together.After the removal, the probe was forcibly pulled from the scope, and the probe was already broken.No patient or user harm has been reported.

Manufacturer Narrative

The subject device has been returned to an olympus repair center for evaluation and inspection, and the customer's reported problem has been confirmed.A considerable amount of twisting and abnormalities have also been observed.This investigation is ongoing, and additional information regarding this event has been requested.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

Updated fields: b5, d8, and h6.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and additional information received from the end user a review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over six years since the subject device was manufactured.Based on the results of the investigation, the following has been observed: ·a myriad of indentations were identified in the apical sheath.·we confirmed that there were myriad tortuosity in the insertion sheath.·it was confirmed that there was no failure in the ultrasonic probe.·it was confirmed that there was no hole in the tip sheath and the insertion sheath, and that there was no leakage of the ultrasonic medium.·it was confirmed that the internal blade (flexible shaft) did not drive normally.·it was confirmed that the ultrasonic image was not depicted normally.·guide sheath of the combination equipment was confirmed, and it was confirmed that an infinite number of twists were generated in the sheath.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.

Event Description

The procedure was a diagnostic cytodiagnosis, and there were no procedural delays.

• 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: 16336566
• MDR Text Key: 309596561
• Report Number: 3002808148-2023-01230
• 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,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• 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: 01/17/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2016
• 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: BF-P290; SG-200C