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 Hemorrhage/Bleeding (1888); Pneumothorax (2012)

Event Date 11/03/2023

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled "performance of radial endobronchial ultrasound for peripheral pulmonary lesions without automation technology in tuberculous endemic region: real-world experience in a single institution over 6 years." this is a retrospective chart review of all adult patients undergoing radial endobronchial ultrasound (rebus)-guided transbronchial biopsy for peripheral pulmonary lesions (ppl) over 6 years duration (october 2016 to december 2022).Various flexible conventional (bf-h190), thin bronchoscopes (bf-mp190-f), radial ebus probes (um-s20-17s), guide sheath (k-201 ) and an endobronchial balloon (b5-2c) were used for the procedures.During the study period, a total of 558 procedures were performed.Seven cases were excluded due to the presence of visible endobronchial lesions during initial scouting bronchoscopy.The final number of procedures available for analysis was 551.Pneumothoraxes: 1.1% - requiring percutaneous drainage mild bleeding: 22.1% moderate bleeding: 5.3%.

Manufacturer Narrative

This report is related to the following linked patient identifiers: (b)(6).The literature article is attached for additional information.The author was not reachable to obtain any further information.The investigation is ongoing, and this report will be supplemented when new and relevant information becomes available later.

Manufacturer Narrative

For h4 a default date of 1/1/1950 is used since the serial number(s) of the reported device(s) has not been made known to olympus.Based on the investigation, since the subject device was not returned and no malfunction was documented or reported, a causal relationship between the product and the health hazards could not be determined.The serial number is unknown.Olympus will continue to monitor field performance for this device.A supplemental report will be submitted if additional information becomes available.

Event Description

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.

• 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: 18764740
• MDR Text Key: 336051283
• Report Number: 3002808148-2024-30945
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K982323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/1950
• 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
• Patient Outcome(s): Required Intervention