MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC PROBE

Model Number UM-S20-17S

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned for investigation.Upon evaluation of the device, probe damage at the distal end was noted.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.

Event Description

It was reported the ultrasonic probe has a distal end leak during reprocessing.There was no patient involvement, no harm or user injury reported due to the event.

Manufacturer Narrative

This follow up report is being submitted to include the device history record(dhr) review and results from the legal manufacturer investigation.The legal manufacturer performed the dhr review for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.The probable cause of the ultrasonic medium leaking from the probe tip is because the probe tip was damaged by an external force.It was confirmed that the phenomenon does not occur due to product or manufacturing, and there is no problem with safety.There were no multiple occurrences.The instructions for use (ifu) states: ¿4.1 insertion ¿insertion of the ultrasonic probe through an endoscope ¿do not advance or extend the probe abruptly from the endoscope ¿s distal end.This could result in injury.¿4.3 withdrawal ¿withdrawing from the endoscope do not withdraw the ultrasonic probe from the endoscope quickly.Blood, mucous, or other patient debris could spray, posing an infection-control risk.¿ when withdrawing the ultrasonic probe, always set the endoscopic ultrasound system to the freeze mode.Withdrawing when the ultrasonic probe is rotating may damage the probe.¿ when using a gastrointestinal endoscope with a forceps elevator, always lower the forceps elevator before withdrawing the ultrasonic probe.Withdrawing the ultrasonic probe with the forceps elevator raised may damage the ultrasonic probe.Olympus will continue to monitor complaints for this device.

• Brand Name: ULTRASONIC PROBE
• Type of Device: ULTRASONIC PROBE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12178333
• MDR Text Key: 274950103
• Report Number: 8010047-2021-08923
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• Combination Product (y/n): N
• PMA/PMN Number: K982323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/02/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/15/2021
• Supplement Dates Manufacturer Received: 07/30/2021
• Supplement Dates FDA Received: 08/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1