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 Pneumothorax (2012); Respiratory Tract Infection (2420)

Event Date 03/10/2023

Event Type  Injury  

Manufacturer Narrative

Since the literature described "1.4- or 1.7 mm rebus probe (um-s20-17s or um-s20-20s)", olympus selected "um-s20-17s" as the representative device.This report is related to the following linked patient identifiers: 1.(b)(6).The literature article is attached for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

Olympus reviewed a literature titled "computed tomography bronchus sign subclassification during radial endobronchial ultrasound-guided transbronchial biopsy: a retrospective analysis." this was a retrospective study of consecutive patients who underwent radial endobronchial ultrasound transbronchial biopsy (rebus-tbb) for peripheral pulmonary lesions between (b)(6) 2015 and (b)(6) 2017.Patients with central pulmonary lesions (ppls) with evidence of endobronchial involvement, those who underwent re-examination for the same lesion, those with unknown final diagnosis due to loss at follow-up, and those with lack of evaluation by high resolution ct (hrct) imaging of lesions that were less than 1mm in thickness were excluded.The study concludes that ct bronchus sign subclassification may provide useful information to facilitate the selection of bronchoscopic techniques for accurate diagnosis of ppls.Rebus-tbb generally had an acceptable diagnostic performance in ct-bs group i.However, type ic is exceptional, and it may be useful to obtain larger samples with a 1.9 mm forceps (or consider cryoprobes).Rebus-tbb is not expected to provide sufficient diagnostic performance in ct-bs group ii; therefore, newer guided bronchoscopic techniques appropriate for each bronchus type should be considered.Overall, 9 patients presented with pneumothorax, among whom five required chest tube drainage and twenty-eight developed pulmonary infection.Type of adverse events/number of patients pneumothorax - 9 patients pulmonary infection - 28 patients.

Manufacturer Narrative

Updated fields:h4, h6.For h4 a default date of (b)(6) 1950 is used since the serial number(s) of the reported device(s) has not been made known to olympus.Based on the investigation, since the subject device was not returned and no malfunction was documented or reported, a causal relationship between the product and the health hazards could not be determined.The serial number is unknown.Olympus will continue to monitor field performance for this device.A supplemental report will be submitted if additional information becomes available.

Event Description

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.

• 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18822742
• MDR Text Key: 336733067
• Report Number: 3002808148-2024-31159
• 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: 04/23/2024

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
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/1950
• 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.; BF-P290.; K-202.; NA-1C-1.
• Patient Outcome(s): Required Intervention