MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ULTRASONIC PROBE; FLEXIBLE ENDOSCOPIC ULTRASOUND IMAGING TRANSDUCER

Model Number UM-S20-17S

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/08/2022

Event Type  malfunction  

Event Description

The customer reported to olympus, the tip of ultrasonic probe fell off during reprocessing.There was no report of patient harm associated with this event.

Manufacturer Narrative

To date, the device has not been returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

Additional information was provided regarding this event.The event occurred during reprocessing.The intended procedure was diagnostic confirming mass with radial ebus (endobronchial ultrasound) in ion robotic.The patient was under general anesthesia.It was completed using the subject device and without delays.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation.The subject device was returned to olympus for evaluation.During inspection and testing, the allegation was confirmed.The protective sheath was torn off in the middle of probe with internal oil leaking out.In addition, unable to display ultrasound image due to a faulty probe.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.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, it is likely that the leak of the ultrasound medium occurred because there was a hole on the probe tip (sheath).The tip of the insertion section was likely pushed, pulled, or hit while the subject device was driven, and the insertion section was bent.This resulted in generating a dent, and the ultrasound transducer was damaged.However, a root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿do not push or pull the ultrasonic probe with strong force while the ultrasonic probe is driven (unfreeze state) or pull it into the curved part of the endoscope.If you push or pull the ultrasonic probe with a strong force or abrupt movements, the image may be distorted, or the ultrasonic probe may be damaged.¿ olympus will continue to monitor field performance for this device.

• Brand Name: ULTRASONIC PROBE
• Type of Device: FLEXIBLE ENDOSCOPIC ULTRASOUND IMAGING TRANSDUCER
• 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: 15952195
• MDR Text Key: 308483344
• Report Number: 3002808148-2022-05067
• 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: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2022
• 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