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

Model Number UM-S20-17S

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.While evaluating the device, the user report of blood in the probe tip was confirmed.Additionally, it was noted that the unit failed to display the ultrasound image.If additional information becomes available following device evaluation, a supplemental report will be filed.

Event Description

It was reported, the distal end of the ultrasonic probe contained blood inside of it after being used approximately "10-15 times".There was no patient harm or consequence reported as a result of this event.

Event Description

Additional information was received from the user facility noting that the event date was 30dec2020.The customer also stated the problem was first noticed during reprocessing.The procedure being performed was a diagnostic bronchoscopy.The concomitant device was robotic bronchoscope.It was also stated that the intended procedure was completed using the same device with no delays.Furthermore, the customer confirmed that the probe was inspected prior to use and was deemed in good condition.However, after the procedure was completed, while cleaning the device, blood was noted.The device was cleaned and disinfected with an opa.

Manufacturer Narrative

Investigation is still ongoing.However, should additional information become available prior to the conclusion of the investigation, a supplemental report will be provided.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.A review of the device history record (dhr), and a review of the instructions for use (ifu) were conducted during this investigation.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.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.¿ since blood has invaded the inside of the main body, it is considered that there is a hole in the insertion part.The hole may have been created by pushing or pulling the um-s20-17s or pulling it out vigorously while an external force was applied to the insertion part.Meaning, the tip of the insertion part would have been damaged if the endoscope is curved, pushed or pulled while the um-s20-17s was driven, or if it was removed at once or vigorously when it was removed from the endoscope.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: 11217766
• MDR Text Key: 243690220
• Report Number: 8010047-2021-01744
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• 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: 01/11/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1