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

Model Number UM-S20-17S

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.During the evaluation, the reported issue was confirmed.The probe tip was found damaged and the body contained kinks.The device was returned to the customer unrepaired.If additional information is obtained a supplemental report will be filed.

Event Description

A user facility reported defects on an ultrasonic probe, something was spinning at the end of the scope.No patient involvement or injury was reported.No additional information has been obtained.

Manufacturer Narrative

The investigation has been completed.A device history record (dhr) review was performed and found no non-conformances that would cause the reported malfunction.All records indicate that the device was manufactured in accordance with all applicable procedures.The instructions for use (ifu) states: ¿do not place the ultrasonic probe in unclean environment.This could result in injury and pose an infection control risk).To prevent damage to the ultrasound center and/or the probe driving unit, make sure that the ultrasound center is turned off before connecting or disconnecting the ultrasonic probe to the probe driving unit.¿ the root cause could not be conclusively determined.Probable causes that could have led to the reported event include an external force was applied to the tip sheath, which may have resulted in the damage of the ultrasonic probe.

• 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: 10754676
• MDR Text Key: 214593631
• Report Number: 8010047-2020-08286
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 12/08/2020
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1