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

Model Number UM-S20-17S

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

Patient Problems Fever (1858); Hemorrhage/Bleeding (1888); Hypoxia (1918); Pneumothorax (2012); Unspecified Respiratory Problem (4464)

Event Date 10/24/2022

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Olympus medical systems corp.(omsc) received a literature titled "diagnostic yield and safety of cp-ebus-tbna and rp-ebus-tblb under moderate sedation: a single-center retrospective audit".This retrospective review study aimed to describe the diagnostic yield and safety of cp-ebus-tbnas and rp-ebus-tblbs when performed under moderate sedation in 421 patients.The diagnostic yield of the cp-ebus-tbnas and rp-ebus-tblbs were 62.5% and 71.6%, respectively.The most frequent diagnosis for cp-ebus-tbnas were malignancy, sarcoidosis, and mycobacterium infection (50.9%, 6.3%, and 4.2%, respectively).The most frequent diagnoses for rp-ebus - tblbs were malignancy, organizing pneumonia, and mycobacterium infection (45.8%, 10% and 3.7%, respectively) this study concludes that performing cp-ebus-tbnas and rp-ebus-tblbs under moderate sedation is safe and provides good diagnostic yield.Type of adverse events/number of patients.Bleeding - 50 patients.Pneumothorax - 1 patient.Hypoxia - 2 patients.Respiratory complaints or fever - 10 patients.This literature article requires 6 reports.The related patient identifiers are as follows: (b)(6)/na-201sx-4022.(b)(6)/bf-uc260fw.(b)(6)/fb-231d.(b)(6)/bf-q290.(b)(6)/bf-260.(b)(6)/um-s20-17s.This medwatch report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.

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 and/or lot 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, the relationship between the device and the adverse events cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.

Event Description

Additional information received from the author confirming there were no malfunction of the olympus equipment and the reported complications are comparable to reported complications in literature.

• Brand Name: ULTRASONIC PROBE
• Type of Device: ULTRASONIC PROBE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16159829
• MDR Text Key: 307312484
• Report Number: 9614641-2023-00058
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K982323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• 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: 05/25/2023
• 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
• Patient Outcome(s): Other; Required Intervention