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

Model Number UM-S20-17S

Device Problem Material Integrity Problem (2978)

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

Event Date 02/02/2024

Event Type  malfunction  

Manufacturer Narrative

The device was not returned, but the investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

It was reported that the ultrasonic probe had oil wiping off of the tip.The reported malfunction occurred during reprocessing.There were no reports of patient injury or medical intervention associated with this event.

Manufacturer Narrative

This report is being supplemented to provide additional information, based on the legal manufacturer's final investigation and device evaluation.The device was not returned to olympus for evaluation.The evaluation was conducted solely on available information.The customer's complaint was unable to be confirmed.However, a most probable cause of the reported event is component failure, which is expected or random component failure without any design or manufacturing issue.The device history record (dhr) was unable to be reviewed for this device, as the serial number was deemed invalid.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the definitive root cause of the issue could not be determined.Olympus will continue to monitor field performance for this device.

Event Description

It was reported, that the ultrasonic probe had oil wiping off of the tip.The reported malfunction occurred, during reprocessing.There were no reports of patient injury or medical intervention associated with this event.

• 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18816913
• MDR Text Key: 337740442
• Report Number: 3002808148-2024-31119
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2024

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 05/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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