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

Model Number UM-S20-17S

Device Problem Break (1069)

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

Event Date 02/06/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned and the evaluation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.

Event Description

It was reported, the subject device broke in half during the test period of a procedure.The procedure was completed using a similar device.There was no patient impact, no harm reported due to the event.

Event Description

This report is being supplemented based on additional information provided by the completed investigation.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The device was returned to olympus for inspection and the reported failure was confirmed; the device broke in half.Based on the results of the investigation, it is likely the following led to the malfunction: the most probable cause of this complaint was traced to component failure.A review of the device history record found no deviations that could have caused or contributed to the reported issue.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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18864743
• MDR Text Key: 337742895
• Report Number: 3002808148-2024-31290
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

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?: Yes
• Date Returned to Manufacturer: 02/08/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 03/08/2024
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2023
• 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