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

Model Number UM-G20-29R-3

Device Problem Gel Leak (1267)

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

Event Date 05/06/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to omsc for investigation.Omsc checked the subject device and found that the reported phenomenon could not be confirmed and there was no perforation on the subject device.Omsc reviewed the device history record (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, based upon the investigation, there was the possibility that the user observed the part where air bubbles were gathered in the insertion tube, consequently the user mistakenly recognized that it was "missing of the ultrasonic propagation fluid medium", because the user stated the ¿missing¿, not stated the ¿leakage¿.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during preparation for endoscopic ultrasonography procedure, it was found the missing of ultrasonic propagation fluid medium from the insertion tube.The user replaced the subject device with another device and completed the intended procedure.There was no report of patient injury associated with the event.

• 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: 11907212
• MDR Text Key: 280604812
• Report Number: 8010047-2021-06905
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: K001203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial
• Report Date: 05/31/2021

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-G20-29R-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 05/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1