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

Model Number UM-S20-17S

Device Problem Device Reprocessing Problem (1091)

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

Event Date 11/29/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that the ultrasonic probe was coiled less than 20cm and stored in a case instead of a well-ventilated cabinet.There were no reports of patient or user harm.

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 of the event was unable to be identified.The device was not returned to olympus; however, contents of the report from the customer deviates from the contents of the instruction manual.Therefore, it is likely that the phenomenon occurred due to handling of the user.The event can be detected/prevented by following the instructions for use which state: "warnng: do not store the sterile packages containing the instruments in places where they could become damaged, wet, or improperly sealed.Otherwise, the sterility of the instruments may be compromised and pose an infection-control risk or cause tissue irritation.Do not store the ultrasonic probe in the shipping box.Use the box only for shipping the instrument.Routine storage in a humid, nonventilated environment, such as the shipping box, may present an infection-control risk.Caution: the storage cabinet must be clean, dry, well ventilated, and maintained at ambient temperature.Storing the ultrasonic probe in direct sunlight, at high temperatures, in high humidity, or exposed to x-rays may damage the components or present an infection-control risk.Do not coil the ultrasonic probe¿s insertion tube with a diameter of less than 20 cm.Instrument damage such as image flow and impeded or irregular rotation can result.Do not store the ultrasonic probe with the distal end pointing upward.Air bubbles inside the insertion tube will gather at the distal end and result in reduced performance.".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: 18324237
• MDR Text Key: 330944138
• Report Number: 3002808148-2023-14243
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2023
• 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