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 Air Embolism (1697); Dyspnea (1816); Fever (1858); Headache (1880); Hemoptysis (1887); Hemorrhage/Bleeding (1888); Hypoxia (1918); Unspecified Infection (1930); Pneumothorax (2012); Vomiting (2144); Sore Throat (2396); Respiratory Failure (2484); Bronchospasm (2598); Fibrosis (3167); Syncope/Fainting (4411); Pleural Empyema (4459); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/11/2023

Event Type  Injury  

Event Description

Olympus medical systems corp.(omsc) received a literature titled "thirty-day complications, unplanned hospital encounters, and mortality after endosonography and/or guided bronchoscopy: a prospective study." background and objective: limited data exist regarding the adverse events of advanced diagnostic bronchoscopy, with most of the available information derived from retrospective datasets that primarily focus on early complications.Methods: we conducted a 15-month prospective cohort study among consecutive patients undergoing endosonography and/or guided bronchoscopy under general anesthesia.We evaluated the 30-day incidence of severe complications, any complication, unplanned hospital encounters, and deaths.Additionally, we analyzed the time of onset (immediate, within 1 h of the procedure; early, 1 h¿24 h; late, 24 h¿30 days) and identified risk factors associated with these events.Results: thirty-day data were available for 697 out of 701 (99.4%) enrolled patients, with 85.6% having suspected malignancy and multiple comorbidities (median charlson comorbidity index (iqr): 4 (2¿5)).Severe complications occurred in only 17 (2.4%) patients, but among them, 10 (58.8%) had unplanned hospital encounters and 2 (11.7%) died within 30 days.A significant proportion of procedure-related severe complications (8/17, 47.1%); unplanned hospital encounters (8/11, 72.7%); and the two deaths occurred days or weeks after the procedure.Low-dose attenuation in the biopsy site on computed tomography was independently associated with any complication (or: 1.87; 95% ci 1.13¿3.09); unplanned hospital encounters (or: 2.17; 95% ci 1.10¿4.30); and mortality (or: 4.19; 95% ci 1.74¿10.11).Within the 30-day follow-up period, 24 patients died (3.4% all-cause mortality), but only 2 deaths were considered related to the procedure (0.29% procedure-related mortality) (table 4).One patient developed a coma due to an air embolism during a combined endosonography and guided bronchoscopy procedure.During the icu stay, the patient experienced respiratory failure requiring intubation and mechanical ventilation due to bilateral pneumonia.He ultimately died 28 days after the procedure, with septic shock identified as the final cause of death.The second patient died 19 days after a combined endosonography and guided bronchoscopy procedure due to an acute exacerbation of idiopathic pulmonary fibrosis (ipf).Of note, the majority of patients had an underlying malignancy (85.6%) and multiple comorbidities, with a median charlson comorbidity index (cci) of 4 (iqr 2¿5).Out of the 456 patients who were ultimately diagnosed with primary lung cancer, 47 (10.3%) were classified as being in stage i, 37 (8.1%) in stage ii, 96 (21.1%) in stage iii, and the majority in stage iv (261, 57.2%); the remaining 15 (3.3%) patients underwent endosonography and/or guided bronchoscopy, as they were found to have a suspected relapse of a previously treated lung cancer.Conclusions: severe complications arising from endosonography and guided bronchoscopy, although uncommon, have significant clinical consequences.A substantial proportion of adverse events occur days after the procedure, potentially going unnoticed and exerting a negative clinical impact if a proactive surveillance program is not implemented.Type of adverse events/number of patients: event 1:immediate, severe, complications (air embolism (1), bleeding grade >=3 (1)) (table 2) event 2:immediate, mild/moderate, complications (laryngobronchospasm (17), bleeding grade <=2 (16), transient but sustained hypoxemia (3)) (table 2).Event 3:early, severe, complications (respiratory failure (4), pneumothorax (1), acute coronary syndrome (1)) (table 2).Event 4:early, mild/moderate, complications (*fever(7), transient (<24 h) respiratory failure (2), persistent sore throat (2), vasovagal syncope (1), persistent headache/vomiting (1)) (table 2).Event 5:late, severe, complications (pulmonary infection (2), severe hemoptysis (2), pulmonary infection and empyema (1), mediastinitis (1), acute exacerbation of pulmonary fibrosis (1), respiratory failure (1)) (table 2).Event 6:late, mild/moderate, complications (hemoptysis (9), *fever (7), worsening dyspnea (4)) (table 2).Event 7:**unplanned hospital encounters (uhe) (11) (table 4).Event 8:death (non-procedure related (22), procedure related (2)) (table 4).Fever was defined as > 38 c occurring after the procedure, with a duration > 12 h and requiring antibiotic treatment because of a lack of response to paracetamol.**causes of procedure-related unplanned hospital encounters included: respiratory failure (2), severe hemoptysis (2), pneumonia (1), mediastinitis (1), sepsis from lung abscess (1), pneumonia with empyema (1), coma due to air embolism (1), acute exacerbation of ipf (1), persistent headache/vomiting (1).This literature article requires 12 reports.The related patient identifiers are as follows: 1.(b)(6): bf-uc260fw (procedure-related deaths).2.(b)(6): na-201sx-4021 (procedure-related deaths).3.(b)(6): bf-p190 (procedure-related deaths).4.(b)(6): um-s20-17s (procedure-related deaths).5.(b)(6): fb-433d (procedure-related deaths).6.(b)(6): na-1c-1 (procedure-related deaths).7.(b)(6): bf-uc260fw (adverse events).8.(b)(6): na-201sx-4021 (adverse events).9.(b)(6): bf-p190 (adverse events).10.(b)(6): um-s20-17s (adverse events).11.(b)(6): fb-433d (adverse events).12.(b)(6): na-1c-1 (adverse events).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

Health effect - clinical code 4581 is used to code for acute coronary syndrome and mediastinitis.The suspect device has not been returned to olympus.Additional information has been requested.The literature is attached for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.

Event Description

An olympus device did not malfunction during any of the procedures described in the literature article.In addition, an olympus device did not cause or contribute to any of the adverse events.

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.This supplemental report includes a correction to g2 to provide information that was inadvertently not included on the initial medwatch.Also, additional information received from the author has been added to b5.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: 17911457
• MDR Text Key: 325369087
• Report Number: 3002808148-2023-11091
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K982323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• 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: 12/05/2023
• 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): Required Intervention; Hospitalization