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

Model Number UM-S20-17S

Device Problems Gel Leak (1267); Output Problem (3005)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to omsc for evaluation.The ultrasonic image was not depicted normally.There was a dent on the distal end sheath.There was a hole and a fuzz in the insertion part sheath.The ultrasonic probe was not damaged.The distal end sheath was cut in order to check whether there was an ultrasonic medium.As a result, no ultrasonic medium remained inside.The device was driven normally.The manufacturing record was reviewed and found no irregularities.Omsc presumed that the reported event was that the ultrasonic images could not be depicted normally.Omsc presumed that the ultrasonic waves could not be transmitted normally, and the ultrasonic images could not be depicted normally because holes occurred in the insertion part sheath and the ultrasonic medium leaked out and decreased.

Event Description

Olympus medical systems corp.(omsc) was informed by the customer that during the bronchoscopy, there was a defect, the runtime had not yet been reached.The procedure was not completed.There was no report of patient injury associated with the event.The event date was unknown.The subject device was returned to omsc for evaluation.On (b)(6) 2021, omsc found that there was a leakage of ultrasonic medium.

• 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: 12148449
• MDR Text Key: 280508233
• Report Number: 8010047-2021-08690
• 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: 07/12/2021

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: No Information
• Device Model Number: UM-S20-17S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/18/2021
• Initial Date FDA Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1