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

Model Number UM-S20-20R-3

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

Patient Problems Hemorrhage/Bleeding (1888); Pneumothorax (2012)

Event Date 12/12/2022

Event Type  Injury  

Event Description

Olympus reviewed a literature titled "when pulmonologists are novice to navigational bronchoscopy, what predicts diagnostic yield?".Literature summary: predicting factors of diagnostic yield in electromagnetic navigation bronchoscopy (enb) have been explored in a number of previous studies based on data from experienced operators.However, little is known about predicting factors when the procedure is carried out by operators in the beginning of their learning curve.We here aim to identify the role of operators¿ experience as well as lesion¿ and procedure characteristics on diagnostic yield of enb procedures in the hands of novice enb operators.Four operators from three centers without prior enb experience were enrolled.The outcome of consecutive enb procedures was assessed and classified as either diagnostic or non-diagnostic and predicting factors of diagnostic yield were assessed.A total of 215 procedures were assessed.A total of 122 (57%) of the enb procedures resulted in diagnostic biopsies.Diagnostic enb procedures were associated with a minor yet significant difference in tumor size compared to non-diagnostic/inconclusive enb procedures (28 mm vs.24 mm; p = 0.03).Diagnostic enb procedures were associated with visible lesions at either fluoroscopy (p = 0.003) or radial endobronchial ultrasound (rebus), (p = 0.001).In the logistic regression model, lesion visibility on fluoroscopy, but none of operator experience, the presence of a bronchus sign, lesion size, or location nor visibility on rebus significantly impacted the diagnostic yield.In novice enb operators, lesion visibility on fluoroscopy was the only factor found to increase the chance of obtaining a diagnostic sample.Type of adverse events/number of patients: pneumothorax requiring chest tube insertion occurred in 2 patients bronchopulmonary hemorrhage requiring a balloon catheter occurred during one procedure.This event requires three reports patient identifier (b)(6) is for the evis exera iii bronchovideoscope.Patient identifier (b)(6) is for the disposable biopsy forceps.Patient identifier (b)(6) is for the ultrasonic probe.This report is for (b)(6).

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.

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 event 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.

• 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: 18306863
• MDR Text Key: 330223955
• Report Number: 3002808148-2023-14092
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K001203
• 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: 12/18/2023

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-S20-20R-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: 12/15/2023
• Supplement Dates FDA Received: 12/18/2023
• 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: DISPOSABLE BIOPSY FORCEPS ¿ LOT UNK; EVIS EXERA III BRONCHOVIDEOSCOPE ¿ SN UNK
• Patient Outcome(s): Required Intervention