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

Model Number UM-S20-17S

Device Problems Break (1069); Mechanical Jam (2983)

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

Event Date 03/09/2021

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed from the user that it was found that the subject device was stuck in the guide sheath and the subject device could not be pulled out.The issue occurred when the subject device was removed from the guide sheath during the bronchoscopy.There was no report of patient injury associated with the event.

Manufacturer Narrative

The subject device was returned to olympus (b)(4).(b)(4) checked the subject device and removed both the subject device and the guide sheath at the same time and they passed through the endoscope with no difficulties.Then the subject device was returned to omsc for investigation with stuck in the guide sheath.Omsc checked the subject device and found following; - the subject device had a cut inside the guide sheath - the x-ray tip of the guide sheath was deformed and became oval shape, also the tube of the guide sheath was kinked.Omsc reviewed the device history record (dhr) of the subject device and confirmed no irregularity.Based upon the investigation, omsc surmised that the reported phenomenon was attributed to the stress was applied to the x-ray opaque tip due to the angle of the endoscope was strict when the endoscope was inserted.The phenomenon was caused by crashed radiopaque tip being deformed and stuck inside the guide sheath.Crashed radiopaque may have been attributed to a load applied to it when angulation too much during insertion of the endoscope.Olympus stated the appropriate handling of um-s20-17s and the counter measures against abnormalities in the instruction manual of um-s20-17s.

• 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: 12605498
• MDR Text Key: 281324639
• Report Number: 8010047-2021-12986
• Device Sequence Number: 1
• Product Code: ITX
• 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
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UM-S20-17S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1