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 Pneumonia (2011); Low Oxygen Saturation (2477); Decreased Appetite (4569)

Event Date 09/07/2023

Event Type  Injury  

Event Description

Olympus medical systems corp.(omsc) received a literature titled "close-to-lesion transbronchial biopsy: a novel technique to improve suitability of specimens for genetic testing in patients with peripheral pulmonary lesions".Literature summary bronchoscopy with radial-probe endobronchial ultrasound, a guide sheath, and electromagnetic navigation can improve the diagnostic yield of peripheral lung nodules.However, the suitability of specimens for genetic analysis remains unsatisfactory.We hypothesized that a transbronchial biopsy performed after closely approaching the bronchoscope tip to the lesion might provide more suitable specimens for genetic analysis.We enrolled 155 patients with peripheral pulmonary lesions who underwent bronchoscopy with a thin or ultrathin bronchoscope.Bronchoscopy was performed using virtual bronchoscopic navigation and radial-probe endobronchial ultrasound with a guide sheath.The bronchoscope tip was placed closer to the lesion during bronchoscopy to collect larger specimens with higher malignant cell content.The patients who underwent a close-to-lesion biopsy had higher rates of overall diagnostic yield, histopathological diagnostic yield, and specimen quality for genetic testing than those who did not.The significant determinants of the specimen¿s suitability were the close-to-lesion approach, within-the-lesion image, the use of standard 1.9-mm-forceps, and the number of cancer-cell-positive specimens.The significant predictors of the specimen¿s suitability for genetic analysis were close-to-lesion biopsy and the number of malignant cell-positive tissue samples.This study demonstrates that the close-to-lesion transbronchial biopsy significantly improves the suitability of bronchoscopic specimens for genetic analysis.Type of adverse events/number of patients.Event 1: grade 3 anorexia in 1 patient.Event 2: grade 3 pneumonia in 2 patients.Event 3 : hypoxemia in 2 patients.Two patients in the cl-tbb group required hospitalization, one patient had grade 3 anorexia, and one patient had grade 3 pneumonia.Also, in the non-cl-tbb group- 3 patients required hospitalization, two had grade 3 hypoxemia, and one patient had grade 3 pneumonia.No pneumothorax, bleeding, or bronchial tears that needed therapeutic intervention occurred in either group.This literature article requires 4 reports.The related patient identifiers are as follows: 1, (b)(6 )(bf-p290) 2, (b)(6) (pw-6c-1) 3, (b)(6) (um-s20-17s) 4, (b)(6) (k-202) 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

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: 17878597
• MDR Text Key: 325014662
• Report Number: 3002808148-2023-10828
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/28/2023

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-S20-17S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 11/23/2023
• Supplement Dates FDA Received: 11/28/2023
• 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: EVIS LUCERA ELITE BRONCHOVIDEOSCOPE- SERIAL UNK; SINGLE USE GUIDE SHEATH KIT ¿ LOT UNKNOWN; SPRAY CATHETER ¿ LOT UNKNOWN
• Patient Outcome(s): Hospitalization