MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ULTRASONIC PROBE; FLEXIBLE ENDOSCOPIC ULTRASOUND IMAGING TRANSDUCER

Model Number UM-S20-17S

Device Problems Material Puncture/Hole (1504); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The suspect device was returned to olympus and evaluated.The reported problem was confirmed.The evaluation found that the probe body was damaged in the middle.In addition, the unit failed to display an image that met olympus standards.The investigation is ongoing and the definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

A user facility reported to olympus that during sterilization of the device, steam was present and air bubbles could be seen on the end of the device.The problem, as reported to olympus, was identified during reprocessing of the device.There was no patient injury, associated with the problem, reported to olympus.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to h4, h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely there is a hole perforated in the probe tip and a leak of ultrasonic media has occurred.Additionally, it¿s probable the ultrasonic transducer is damaged by pushing and pulling while the product is driven causing the insertion portion to bend, or by hitting the insertion tip.The root cause of this event was unable to be identified.The event can be prevented by following the instructions for use which state: ¿chapter - usage of this product do not push or pull the ultrasonic probe with strong force while the ultrasonic probe is driven (unfreeze state) or pull it into the curved part of the endoscope.If you push or pull the ultrasonic probe with a strong force or abrupt movements, the image may be distorted, or the ultrasonic probe may be damaged.¿ olympus will continue to monitor field performance for this device.

• Brand Name: ULTRASONIC PROBE
• Type of Device: FLEXIBLE ENDOSCOPIC ULTRASOUND IMAGING TRANSDUCER
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15099274
• MDR Text Key: 304793579
• Report Number: 3002808148-2022-00286
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• 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: 07/05/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2017
• 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