FDA Adverse Event Injury Summary report: N

EVIS EXERA III BRONCHOVIDEOSCOPE

MDR report key: 20917408 · Received December 12, 2024

Report

Report Number
2429304-2024-01035
Event Type
Injury
Date Received
December 12, 2024
Date of Event
June 27, 2024
Report Date
December 12, 2024
Manufacturer
AIZU OLYMPUS CO., LTD.
Product Code
EOQ
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
CA, US
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED ¿ADDED VALUE OF A ROBOTIC-ASSISTED BRONCHOSCOPY PLATFORM IN CONE BEAM COMPUTED TOMOGRAPHY-GUIDED BRONCHOSCOPY FOR THE DIAGNOSIS OF PULMONARY PARENCHYMAL LESIONS.¿ BACKGROUND: CONE BEAM COMPUTED TOMOGRAPHY (CBCT)-GUIDED BRONCHOSCOPIC SAMPLING OF PERIPHERAL PULMONARY LESIONS (PPLS) IS ASSOCIATED WITH SUPERIOR DIAGNOSTIC OUTCOMES. HOWEVER, THE ADDED VALUE OF A ROBOTIC-ASSISTED BRONCHOSCOPY PLATFORM IN CBCT-GUIDED DIAGNOSTIC PROCEDURES IS UNKNOWN. METHODS: WE PERFORMED A RETROSPECTIVE REVIEW OF 100 CONSECUTIVE PPLS SAMPLED USING CONVENTIONAL FLEXIBLE BRONCHOSCOPY UNDER CBCT GUIDANCE (FB-CBCT) AND 100 CONSECUTIVE PPLS SAMPLED USING AN ELECTROMAGNETIC NAVIGATION-GUIDED ROBOTIC-ASSISTED BRONCHOSCOPY PLATFORM UNDER CBCT GUIDANCE (RB-CBCT). PATIENT DEMOGRAPHICS, PPL FEATURES, PROCEDURAL CHARACTERISTICS, AND PROCEDURAL OUTCOMES WERE COMPARED BETWEEN THE 2 COHORTS. RESULTS: PATIENT AND PPL CHARACTERISTICS WERE SIMILAR BETWEEN THE FB-CBCT AND RB-CBCT COHORTS, AND THERE WERE NO SIGNIFICANT DIFFERENCES IN DIAGNOSTIC YIELD (88% VS. 90% FOR RB-CBCT, P=0.822) OR INCIDENCE OF COMPLICATIONS BETWEEN THE 2 GROUPS. AS COMPARED WITH FB-CBCT CASES, RB-CBCT CASES WERE SIGNIFICANTLY SHORTER (MEDIAN 58 MIN VS. 92 MIN, P<0.0001) AND USED SIGNIFICANTLY LESS DIAGNOSTIC RADIATION (MEDIAN DOSE AREA PRODUCT 5114 UGY.M2 VS. 8755 UGY.M2, P<0.0001). CONCLUSION: CBCT-GUIDED BRONCHOSCOPY WITH OR WITHOUT A ROBOTIC-ASSISTED BRONCHOSCOPY PLATFORM IS A SAFE AND EFFECTIVE METHOD FOR SAMPLING PPLS, ALTHOUGH THE INTEGRATION OF A ROBOTIC-ASSISTED PLATFORM WAS ASSOCIATED WITH SIGNIFICANTLY SHORTER PROCEDURE TIMES AND SIGNIFICANTLY LESS RADIATION EXPOSURE. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS PNEUMOTHORAX, OBSERVED ONLY (1 PATIENT) BLEEDING, REQUIRING ESCALATION OF CARE (1 PATIENT) RESPIRATORY FAILURE, REQUIRING ESCALATION OF CARE (2 PATIENTS) CARDIAC EVENT (1 PATIENT) PNEUMOMEDIASTINUM WITHOUT PNEUMOTHORAX RESOLVED ON OWN (1 PATIENT) SEIZURE WITH HEMIPLEGIA IN POST-ANESTHESIA CARE UNIT RESOLVED SPONTANEOUSLY (1 PATIENT). E2402 CODE SELECTED TO REPRESENT PNEUMOMEDIASTINUM.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2407942 EVIS EXERA III BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-1TH190

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Required Intervention EDGE NAVIGATION CATHETER (MEDTRONIC)| PHILIPS AZURION CBCT SYTEM| SIEMENS ARTIS CBCT SYSTEM