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

Model Number UM-S20-17S

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/13/2023

Event Type  Injury  

Event Description

The customer reported to olympus that the distal part of the ultrasonic probe sheath detached in the patient during a diagnostic peripheral exploration examination / pneumology; search for nodule procedure.The practitioner became aware of this at the end of the examination.Another endoscopy was performed but the sheath could not be found, causing the procedure to extend by 15 minutes.It was reported that the sheath was visible on an x-ray.There was no further patient impact reported due to the event.The patient is currently stable.The related medwatch under patient identifier (b)(6) reports a similar occurrence.

Manufacturer Narrative

The customer provided their cleaning, disinfection, and sterilization (cds) process.The device was bathed in anios excel d for ten minutes, rinsed, then bathed again for five minutes.The device was then disinfected with anioxyde by bathing for ten minutes and then rinsing.The hospital cds team was reportedly very familiar with the equipment.The suspect device was returned to olympus; however, evaluation has not yet begun.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 and device evaluation.Additionally, to provide an update to field.The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was confirmed.The evaluation confirmed the following: the tip sheath was broken.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, it is likely the phenomenon "the tip sheath was broken and dropped out into the patient's body" could be due to some impact of the internal blade (flexible shaft) was applied to the sheath during driving, but the sheath on the side that was dislodged could not be removed from the patient's body, so it was not possible to check the failure condition, and it was not possible to determine the factors that occurred.Therefore, the root cause of the phenomenon could not be identified.The event can be prevented by following the instructions for use which state: "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: 17705228
• MDR Text Key: 322924832
• Report Number: 3002808148-2023-09557
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: Yes
• 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: 09/01/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2022
• 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
• Patient Outcome(s): Required Intervention