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

Model Number UM-S20-17S

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/12/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation - specialty procedures gi resource specialist, gi associate, cna.The customer emailed the olympus sales representative (rep) concerning the leaking probe.The rep let the customer know that it sounded like the internal lubricant might be leaking out, and recommended the device be returned.As of now, the device has not been returned.However, if additional information becomes prior to the conclusion of the investigation, a supplemental report will be filed.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.

Event Description

The customer reported that the olympus ultrasonic probe began leaking brown/red fluid during maintenance cleaning.There was no patient involvement during this event.

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.The device was not returned to olympus for evaluation; therefore, a definitive root cause could not be identified.Based on the results of the investigation, there is a possibility that the tip sheath was perforated and caused leakage of the ultrasonic medium.The following statements are included in chapter 4 of the instructions for use which can prevent the event: " 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." and, " 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 field performance 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: 12379712
• MDR Text Key: 277656621
• Report Number: 8010047-2021-10872
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 08/27/2021
• Supplement Dates Manufacturer Received: 09/14/2021
• Supplement Dates FDA Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1