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

Model Number UM-S20-17S

Device Problems Fluid/Blood Leak (1250); Device Contamination with Body Fluid (2317)

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

Event Date 07/14/2022

Event Type  malfunction  

Manufacturer Narrative

This is a combination product during inspection and testing, ultrasonic medium was found to be leaking from the insertion tube and body fluid infiltrated the device.There was an indentation and perforation in the tip sheath.A review of the device history record found no deviations that could have caused or contributed to the reported issues.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, it is likely that, since there was a dent on the tip sheath, it led to leakage of ultrasonic medium and invasion of blood because it reached a hole when some kind of impact was applied to the tip sheath.However, a definitive root cause of the reported issue could not be identified.The device's instruction manual provides the following warning, which may help to prevent the issue: "operation: observation of the ultrasound image observation freeze the image whenever you are not actively viewing the ¿live¿ ultrasound image.When the equipment is in the freeze mode, no ultrasonic waves are emitted into the patient." "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." "do not attempt probe rotation while the ultrasonic probe is advanced abruptly.This could result in image flow and impeded or cause irregular rotation." olympus will continue to monitor field performance for this device.Evaluation of the device found the tip clearance met specification but may have appeared slightly elongated due to impact applied to the tip sheath.In addition, the ultrasonic image was not clear due to bubbles on the tip of the ultrasonic probe.Per the legal manufacturer, these device defects have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.

Event Description

The customer reported that until last year, the ultrasonic probe could be used for approximately one hundred (100) procedures.Over the past year, the probes have started to stretch out after thirty (30) procedures, and three of the probes in use by the customer had defects after 30 procedures.The subject device was sent to olympus for evaluation.During inspection and testing, ultrasonic medium was found to be leaking from the insertion tube and body fluid infiltrated the device.This report is being submitted for the malfunction found during evaluation (leak and liquid infiltration).There was no harm or user injury reported due to the event.

• 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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15635679
• MDR Text Key: 306699240
• Report Number: 3002808148-2022-03354
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• 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
• Date Returned to Manufacturer: 07/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2022
• 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