MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ULTRASONIC PROBE

Model Number UM-2R

Device Problem Device Reprocessing Problem (1091)

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

Event Type  malfunction  

Event Description

The olympus medical service department determined that the customer was missing a required component during reprocessing of the ultrasonic probe while using an olympus endoscope reprocessor (oer-3).The issue was identified during reprocessing of the device.There was no patient involvement, and no patient harm has been reported.The oer-3 olympus endoscope reprocessor was reported in the medwatch with patient identifier (b)(6).

Manufacturer Narrative

D4: the serial number for the device was not provided as it was unknown.Olympus medical service provided training to the customer regarding the reprocessing procedure.The device has not been returned for evaluation.If the device is returned, an investigation will be performed, and a supplemental report will be filed.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, reprocessing was not conducted properly since the wash tube was not used when reprocessing um-2r with oer-3.The event can be prevented by following the instructions for use (ifu) which state: "[please make sure to clean, disinfect (or sterilize) then store the device in accordance with [7.Maintenance method] in page 19, and [8.Storage and disposal] in page 30, after use.When proper cleaning, disinfection (or sterilization) and storage were not conducted, it may lead to infection or damage of the device then function of the device will not be secured.]" olympus will continue to monitor field performance for this device.

• Brand Name: ULTRASONIC PROBE
• Type of Device: ULTRASONIC PROBE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17565504
• MDR Text Key: 321455734
• Report Number: 3002808148-2023-08532
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170063206
• UDI-Public: 04953170063206
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K001203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UM-2R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/23/2023
• Initial Date FDA Received: 08/17/2023
• Supplement Dates Manufacturer Received: 09/11/2023
• Supplement Dates FDA Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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