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

Model Number UM-S20-17S

Device Problem Contamination (1120)

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

Event Date 08/28/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to an olympus repair center for evaluation and the customer¿s reported issue was confirmed.The device evaluation found that the distal end appeared red.In addition it was found that a thin ultrasound image.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Event Description

The customer reported that after performing endobronchial ultrasonography using a guide sheath (ebus-gs) procedure, the medical staff cleaned and disinfected the device using esr-100, but the red stain on the tip could not be removed.There were no reports of harm.

Manufacturer Narrative

Inspection results: the subject device was returned to an olympus repair center for evaluation.The customer¿s reported issue was confirmed; the device evaluation found the distal end appeared red.There was leakage of ultrasound media which is also a reportable malfunction.In addition, the following non-reportable malfunctions were found during the device evaluation: there was a hole and a dent in the tip end sheath; the ultrasound image was not depicted normally.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, and since there was a hole in the tip sheath, it is likely blood got stuck in the tip sheath when it invaded from the hole.Additionally, the ultrasonic medium likely leaked from the the hold at the tip.A definitive root cause of the hole located at the tip end of the sheath cannot be identified.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: 17802420
• MDR Text Key: 324139245
• Report Number: 3002808148-2023-10245
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• 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: Other,Foreign,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/03/2023

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-S20-17S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 09/26/2023
• Supplement Dates FDA Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2023
• 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
• Treatment: BF-1TQ290; BF-P290