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

Model Number UM-S20-17S

Device Problem Defective Component (2292)

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

Event Date 07/10/2023

Event Type  malfunction  

Event Description

The customer reported to olympus the ultrasonic probe had some matter appearing in the probe.The customer was unsure of what the matter was and if anything remained.The customer further indicated that the image was fine at the time of this discovery.There was no patient/user harm or injury reported due to the event.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was unable to be confirmed.During the device evaluation it was observed that there was an abnormal image in comparison to the testing probe.Additionally, it was observed that the probe tip looked damaged and had some color invasion.Due to these findings, the scope was not serviceable and was replaced with a new device.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Additional information about the event was requested, but not received.If new information becomes available, an additional supplemental report will be submitted.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 definitive root cause of the damage and colored material could not be determined.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿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: 17471756
• MDR Text Key: 321377652
• Report Number: 3002808148-2023-08030
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• 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: 07/21/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2022
• 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