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  

Event Description

The service center was informed by the biomedical technician at the user facility that the "sheathing is coming off" the ultrasonic probe during an unspecified event.The biomed technician reported it was "unknown" if there was any patient injury or patient involvement.

Manufacturer Narrative

As part of the investigation, olympus followed up with the user facility to obtain additional information regarding the reported event but with no results.The referenced device was returned to the service center for evaluation.The reported issue was confirmed as the protective sheathing was found torn and peeling off from probe.The device could not be tested in the received condition.The device is non-serviceable and was returned to the user facility unrepaired.The original equipment manufacturer performed the device history records for the concerned device; no abnormalities were found.The investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The concerned device was not returned to the oem for evaluation, therefore the exact cause of the report malfunctions could not be conclusively determined.However, based on the physical evaluation, the potential cause of the reported issue is due to external force.As stated on the ifu (instruction for use) and as a preventive measure, the ifu warns, "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 oem will continue to monitor complaints for this device.

Manufacturer Narrative

This supplemental report was submitted to additional information from the original equipment manufacturer and to update the following sections: d8, g3, g6, h2, h6 and h10.

• 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: 12411385
• MDR Text Key: 280933216
• Report Number: 8010047-2021-11109
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• 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,health
• 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: 09/01/2021
• 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: 03/09/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1