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 Problems Aspiration/Inhalation (1725); Hemoptysis (1887); Hemorrhage/Bleeding (1888); Hematemesis (4478)

Event Date 03/07/2024

Event Type  Injury  

Manufacturer Narrative

E1 facility name: (b)(6) hospital.E2 reflects "y" due to system issue but to correct to "n" as reporter is non-healthcare professional.This report is related to patient identifier: (b)(6), (b)(6).The evaluation of the event is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

It was reported, the ultrasonic probe was used during diagnostic guided sheath procedure.The patient's condition "suddenly changed when the lungs were being lavaged after the biopsy." the patient "vomited a lot of blood." additional information obtained that bleeding occurred, causing a 1-hour delay for hemostasis.The procedure was then completed.The customer commented that there was no problem with the olympus product and the biopsy itself.Further information received that confirmed no change to open surgery.Per the customer, there was a "possibility that the blood was aspirated because it took some time to aspirate after hemoptysis; the bleeding was probably from the biopsy site." the patient recovered well and appeared to be able to communicate the day after the procedure.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved 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, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.

Event Description

It was reported, the ultrasonic probe was used during diagnostic guided sheath procedure.The patient's condition "suddenly changed when the lungs were being lavaged after the biopsy." the patient "vomited a lot of blood." additional information obtained that bleeding occurred, causing a 1-hour delay for hemostasis.The procedure was then completed.The customer commented that there was no problem with the olympus product and the biopsy itself.Further information received that confirmed no change to open surgery.Per the customer, there was a "possibility that the blood was aspirated because it took some time to aspirate after hemoptysis; the bleeding was probably from the biopsy site." the patient recovered well and appeared to be able to communicate the day after the procedure.

• 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: 18975660
• MDR Text Key: 338554095
• Report Number: 3002808148-2024-31654
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• 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
• Date Manufacturer Received: 04/14/2024
• 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: BF-P290 SERIAL (B)(6); CLV-290; CV-290; K-201
• Patient Outcome(s): Required Intervention
• Patient Sex: Male