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

Model Number UM-S20-17S

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/21/2024

Event Type  malfunction  

Manufacturer Narrative

To date, the device has not been returned.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.

Event Description

It was reported that, during reprocessing after the case was completed, only the flexible shaft part of the insertion part of the subject device remained, and about 10 to 15 cm of the outer sheath tip came off.The diagnostic guide sheath method procedure was completed using the same equipment.There were no reports of patient harm.

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 returned to olympus for evaluation and the customer¿s allegation was confirmed.The most probable cause of the findings is that the tip of the insertion part was broken by external force to the tip of the insertion part, and "insertion part tip dropout" occurred.The investigation also identified an insertion tip indentation.A review of the device history record found no deviations that could have caused or contributed to the issue.Based on the results of the investigation, the definitive root cause of the issue could not be determined.Instructions for use (ifu) indicate: ¦chapter 4 usage (warning) ¿ do not insert the ultrasound probe into the endoscope without a clear view of the endoscope.This may result in damage to the tissue in the body cavity and damage to the product." olympus will continue to monitor field performance for this device.

Event Description

It was reported that, during reprocessing after the case was completed, only the flexible shaft part of the insertion part of the subject device remained, and about 10 to 15 cm of the outer sheath tip came off.The diagnostic guide sheath method procedure was completed using the same equipment.There were no reports of patient harm.

• 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: 19136923
• MDR Text Key: 341463527
• Report Number: 3002808148-2024-32281
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• 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
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1