MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC PROBE

Model Number UM-S20-17S

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

Patient Problems Bacterial Infection (1735); Hemorrhage/Bleeding (1888); Pneumonia (2011); Pneumothorax (2012)

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

In the literature titled: "using short-term prophylactic antibiotics for prevention of infectious complications after radial endobronchial ultrasound-guided transbronchial biopsy: prophylactic antibiotics after rebus-tbb,¿ 25 patient experienced post-procedural complications within four weeks of a procedure using an evis lucera bronchofibervideoscope and an ultrasound probe.Study aim: analyze the efficacy of short-term oral antibiotics for preventing infectious complications.Study method: retrospective analysis of 484 patients who underwent radial endobronchial ultrasound-guided transbronchial biopsy (rebus-tbb) from march 2018 to march 2019 did not receive prophylactic antibiotics (¿no prophylactic¿ group, n = 233), while patients who underwent rebus-tbb from april 2019 to march 2020 did receive prophylactics (oral amoxicillin/clavulanate for 3 days; ¿prophylactic¿ group, n = 251).Results: infectious complications occurred in 12 (5.2%) and 2 (0.8%) cases in the no prophylactic and prophylactic groups, respectively.In multivariable analysis, infectious complications were significantly associated with a cavity or low-density attenuation (lda) of the lesion, and with obstructive pneumonic consolidation, but not with prophylactic antibiotics.In subgroup analysis, infectious complications occurred less often when prophylactic antibiotics were used in patients with at least one risk factor (22.4% vs.0%, p = 0.005) conclusions: the risk factors for infectious complications were cavities, lda in the lesion, and obstructive pneumonic consolidation.Use of prophylactic antibiotics might reduce incidence of infectious complications in the presence of these risk factors.Out of 484 patients, there were a total of 25 patients who experience post-procedural complication within four weeks of the rebus-tbb procedure: non-infectious complications - (12).Postprocedural bleeding - (1).Pneumothorax - (11).Infectious complications - (14).Pneumonia - (12).Empyema - (2).Streptococcus sp.- (2).Streptococcus pneumoniae - (2).Staphylococcus aureus - (1).Case with patient identifier (b)(6) reports the scope used in these procedures.Case with patient identifier (b)(6) reports the ultrasound probe used in these procedures.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 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.Olympus will continue to monitor field performance for this device.

• Brand Name: ULTRASONIC PROBE
• Type of Device: ULTRASONIC PROBE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13560297
• MDR Text Key: 290653558
• Report Number: 8010047-2022-03197
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• 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: 03/25/2022
• 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: BF-P260F
• Patient Outcome(s): Other