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

Model Number UM-S20-17S

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to omsc.Omsc investigated the device and confirmed the following: blood was contaminated at the distal end of the sheath section.There was a hole in the distal end of the sheath section, causing an ultrasonic propagation fluid leak.There was a fingernail mark on the distal end of the sheath section.The ultrasonic transducer was damaged.The ultrasound image was not displayed.The exact cause of the reported event could not be conclusively determined, however omsc concluded that blood adhering to the ultrasonic probe may have entered the interior due to the perforation in the distal end of the sheath section.Since there was a fingernail mark at the distal end of the sheath section, there is possibility that a similar external force was applied to the perforated part.Perforation of the distal end of the sheath section may have been caused by an external force.In addition, omsc determined that the ultrasonic propagation fluid inside the ultrasonic probe leaked from the perforated part.External forces on the distal end of the sheath section may have been caused by the following causes: with the ultrasonic probe driven, the ultrasonic probe was pushed and pulled vigorously from the endoscope.With the endoscope bent, the ultrasonic probe was pushed and pulled vigorously from the endoscope.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed by the user that during reprocessing, something like blood was found inside the distal end of the ultrasonic probe.The user wiped off the distal end and the foreign disappeared.It is not sure whether the foreign object adhered to the inside of the tip or the outer surface.Visual inspection by the user facility showed no scratches on the appearance of the ultrasonic probe, and no evidence of water intrusion inside.The device had been reprocessed with an olympus automated endoscope reprocessor model oer-3, after primary cleaning.There was no report of patient injury associated with the event.

• 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: 11234982
• MDR Text Key: 229531643
• Report Number: 8010047-2021-01915
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K982323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• 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: 12/14/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1