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 Hemorrhage/Bleeding (1888); Pneumonia (2011); Pneumothorax (2012)

Event Date 06/10/2022

Event Type  Injury  

Event Description

It is reported in the literature titled ¿diagnostic value of a new cryoprobe for peripheral pulmonary lesions: a prospective study,¿ patients experienced adverse events during/after procedures using olympus devices.Background: cryobiopsy is an established technique that yields larger and higher-quality samples than does a forceps biopsy.However, it remains underutilized in the diagnosis of peripheral pulmonary lesions (ppls), mainly because of difficulties in handling conventional cryoprobes.A recently introduced single-use cryoprobe with a smaller diameter and more flexibility than conventional ones may improve its diagnostic ability for ppls.We con ducted this prospective study to evaluate the feasibility of transbronchial cryobiopsy in the diagnoses of ppls, using a new 1.7-mm cryoprobe.Methods: the study included patients with ppls less than 30 mm in diameter scheduled to undergo bronchoscopy.All the procedures were performed using a combination of virtual bronchoscopic navigation, radial endobronchial ultrasound (r-ebus) and x-ray fluoroscopy, and all the samples were collected using the cryoprobe alone.Thereafter, we assessed the diagnostic outcomes and safety profiles.Results: a total of 50 patients were enrolled and underwent cryobiopsy.The median lesion size was 20.8 mm (range, 8.2¿29.6 mm), and the negative bronchus sign was seen in 34% of lesions.The diagnostic yield was 94% (95% confidence interval, 83.5¿98.8%).A positive bronchus sign had a significantly higher diagnostic yield than did a negative bronchus sign (100% vs.82.4%; p=0.035).The yield was achieved regardless of other variables, including lesion size, location, and r-ebus findings.The major complications were mild and moderate bleeding in 28% and 62% of patients, respectively.Pneumothorax was identified in one patient.Conclusion: transbronchial cryobiopsy using the new 1.7-mm cryoprobe is a feasible procedure that has the potential to increase the diagnostic accuracy for ppls.Mild and moderate bleeding were identified in 14 (28%) and 31 (62%) patients, respectively.Severe bleeding was observed in one patient (2%) who required no further intervention other than suction and transbronchial instillation of thrombogenic agents.Moderate pneumothorax necessitating chest drainage and pneumonia were observed in one patient each.There was no report of device malfunction in any procedure described in this literature.

Manufacturer Narrative

This report is being submitted to report the user's experiences and investigation findings.The devices referenced in this report were not returned to olympus for physical evaluation.The device history record (dhr) for the complaint devices could not be reviewed since the serial numbers were not provided.Olympus does not ship any device that does not meet all design and safety specifications.Conclusion: no malfunction of any olympus device was reported in any procedure described in this article.From the information reported, it is presumed that the causes of the reported events are not due to product defects, but the definitive cause could not be established.

Manufacturer Narrative

This report is being supplemented to provide additional information received from the author.This new information has been added to b5.Also, additional information added to h6.

Event Description

The following additional information regarding the events described in the clinical article was received from the author: an olympus device did not cause or contribute to any adverse event described in the clinical article.In addition, an olympus device did not malfunction during any of the surgical cases.

• 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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15446367
• MDR Text Key: 300158999
• Report Number: 3002808148-2022-02158
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

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: 08/21/2022
• Initial Date FDA Received: 09/19/2022
• Supplement Dates Manufacturer Received: 09/13/2022
• Supplement Dates FDA Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2021
• 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; Other