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

Model Number UM-S20-17S

Device Problems Break (1069); Material Separation (1562)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The user¿s complaint was confirmed.The device was visually inspected and found probe tip damage and the probe body has kinks.The unit is not repairable and was sent back to the user facility.

Event Description

The user facility reported that there was a problem with the device during a procedure.Something is spinning at the end of the scope.The tip came out of the probe.There was no patient injury or harm.No additional information was provided.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.The device evaluation, a review of the device history record (dhr), and a review of the instructions for use (ifu) were conducted during this investigation.The device evaluation found the ultrasonic probe¿s distal end was damaged, this suggests that external force was applied to the distal end of the insertion tube.It is presumed that this caused the distal end of the insertion tube to be damaged and become unstable, which led to rotation of the ultrasonic probe¿s distal end.The ifu contains the following statements: ¿do not hit, stretch, twist, drop, or bend excessively the distal end, insertion section, or connector section of the ultrasonic probe.Otherwise, the equipment may be damaged, causing an injury in the body cavity, burns, bleeding, perforation, or detachment of parts.¿ the review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The root cause could not be determined.Probable causes include improper handling of the device.Olympus will continue to monitor the field performance of this device.

• 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: 10722038
• MDR Text Key: 224958975
• Report Number: 8010047-2020-08023
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• 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: 10/01/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1