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

Model Number UM-S20-17S

Device Problems Leak/Splash (1354); Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2021

Event Type  malfunction  

Manufacturer Narrative

The device is planned to be returned to omsc but has not been returned yet.The user requested investigation of the cause and component analysis of the object that entered the ultrasonic transducer.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed by the user that during the reprocessing, a red-black object such as blood got into the vicinity of the ultrasonic transducer at the distal end of the ultrasonic probe and could not be removed by washing.There was no report of patient injury associated with the event.The ultrasound probe um-s20-17s was used for endoscopy in combination with the endoscopic ultrasound center eu-me1.The device had been highly level disinfected with an olympus automated endoscope reprocessor model oer4 after precleaning.

Manufacturer Narrative

The device was returned to olympus medical systems corp.(omsc) on august 5, 2021.It was then sent to the research department of omsc on august 20, 2021.The research department of omsc investigated the device and found the following: -blood was mixed in the insertion tube at the distal end of the ultrasonic probe.-there was a node in the insertion tube at the distal end.-there was a hole in the insertion tube at the distal end, leaking the ultrasonic propagation fluid medium.This failure mode is a mdr reportable malfunction.-the ultrasonic probe um-s20-17s was driven normally.-the ultrasonic image could not be drawn normally due to the leakage of the ultrasonic propagation fluid medium.Since the insertion tube at the distal end was scratched and punctured, it is possible that blood was mixed inside the insertion tube and the ultrasonic propagation fluid medium.The instruction manual provides precautions for handling the ultrasonic probe um-s20-17s.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.

• 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: 12323085
• MDR Text Key: 266661107
• Report Number: 8010047-2021-10268
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• 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: 08/05/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1