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

Model Number UM-S20-17S

Device Problem Leak/Splash (1354)

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

Event Date 10/05/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The endoscope support specialist (ess) visited the facility and discussed the reprocessing process and scheduled an observation on 12oct2023.During the scheduled observation, a radial probe reprocessing and infection control in-service was performed.The ess also observed manual cleaning and preparation of the scope for eto.The ess covered infection control information referenced in the user manual and reprocessing manual.The customer uses a non-olympus eto sterilization company to sterilize radial probes and it was recommended that the customer contact that manufacturer for its proper use.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus the ultrasonic probe was leaving oil stains on the sterile pouches.The issue was found after a non-olympus ethylene oxide (eto) sterilization company sterilized the radial probes.There were no reports of patient harm.The related patient identifiers are: (b)(6).This medical device report is for patient identifier (b(6).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause was unable to be determined.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: 18004769
• MDR Text Key: 326510939
• Report Number: 3002808148-2023-11784
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2023
• 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