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 No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

The customer reported to olympus that the distal part of the ultrasonic probe sheath detached in the patient during an unspecified procedure upon removal of the probe from the operator channel and was recovered.The event reportedly occurred about 6 months prior to notification date; hence, there was no further information on the event.There was no further patient impact reported from the event.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 will not be returned.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 correction to the initial with information inadvertently left out b5 and g2.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 phenomenon "distal end of the sheath fell inside the patient¿s body.It was not found at the time of endoscopy." occurred due to the tip of the probe was broken.The root cause could not be identified.Additionally, it is possible the phenomenon "tip of the probe is broken" could have occurred due to the handling methods of users.However, a specific root cause could not be determined.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.

Event Description

Additional information received: the distal part of the sheath of the mini probe became detached in the patient during the peripheral exploration examination.The practitioner became aware of this at the end of the examination, and was unable to find the sheath when performing a new endoscopy.The sheath visible on x-ray.

• 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: 17705229
• MDR Text Key: 322924703
• Report Number: 3002808148-2023-09558
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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