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

Model Number UM-S20-17S

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

The device in this report has not been returned to olympus medical systems corp.(omsc) for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

At the end of the bronchoscopy, the user found that a small piece of the distal end of the ultrasound probe fell off in the patient's body.The user removed the small piece from the patient body.The user took an x-ray analysis for the patient and confirmed that the piece was not left in the patient's body.There was no extension of the procedure relevant clinically.There were no reports of patient injuries related to this incident.The user facility did not provide other detailed information.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The device was evaluated at olympus repair center.According to the evaluation, olympus repair center found that the fractured part of the device was not flat.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The exact cause of the reported event could not be conclusively determined.Omsc surmised that this phenomenon attributed to the applied external stress to the device.If significant additional information is received, this report will be supplemented.

• 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: 12038313
• MDR Text Key: 257458635
• Report Number: 8010047-2021-07811
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• 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: 06/17/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1