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

Model Number UM-S20-17S

Device Problems Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

There is no additional information available for this event.Event date is not known.Supplemental report(s) will be filed as any information becomes available.The device has been returned and a device evaluation completed for it.The user¿s complaint was confirmed.The device history record review confirmed that device there were no abnormalities, special adoption, or variations in manufacturing.The device shipping was normal.Upon inspection and testing, it was observed that the device shook violently due to probe body twisted in the middle and the probe tip is deformed.The cause of this issue is not related to manufacture or development of device.Possible cause for the issue could be that an external force was applied to the sheath of the insertion section or the sheath of the tip while the actual product was driving, and the sheath and the internal blade were engaged and twisted.However, the root cause for the issue could not be conclusively determined.Instructions for use (ifu) for preparation and inspection, inspection of the endoscopic system, include statements as below: 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.Never disconnect the ultrasonic probe from the probe driving unit when using real-time mode (i.E., while the ultrasonic transducer is rotating).This could result in damage to the ultrasonic probe and/or probe driving unit.

Event Description

As reported for this event, during set up for an unknown procedure the device mini probe twisted when plugged into the processor.There is no patient involvement.There is no harm or adverse impact to any patient or anyone else.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10617601
• MDR Text Key: 223662048
• Report Number: 8010047-2020-07103
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K982323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• 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: 06/01/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1