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

Model Number UM-S20-17S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pneumothorax (2012)

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The root cause cannot be determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.This report was submitted by the importer under the importer's report number: 2429304-2023-00082.

Event Description

A company representative, on behalf of a user facility, reported that during a guided flexible bronchoscopy biopsy of a left upper lobe lung nodule, the ultrasonic probe got stuck.There was coiling and kicking of the probe.Specifically, the component external to the guide catheter distally (within the patient) and proximally external to the bronchoscope (outside the patient).The coiling and kicking resulted in damage to the patient's lung and inability to remove the probe, guide sheath, and bronchoscope.The case was aborted after the event but required about 1.5 hours to remove the probe from the patient.The patient experienced a pneumothorax and required two urgently placed chest tubes.A ct scan showed interval development of a large pneumatocele from the coiled radial probe.The patient was also hospitalized as a result of the event.It was stated that there were no error messages while the event happened.Additionally, the physician inspected the devices before use and found no defects.There were no malfunctions of any device, and no damage on the scope.The guide sheath was kinked from the radial probe but was intact.It had no other deformity or damage that caused it to coil and kick.Additional information on the patient's outcome has been requested, but not received.

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, since the device was not returned for an evaluation, a root cause could not 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: 16809472
• MDR Text Key: 313949797
• Report Number: 3002808148-2023-04159
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UM-S20-17S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2023
• 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
• Treatment: UNKNOWN BRONCHOSCOPE
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening