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); Pneumothorax (2012)

Event Date 09/16/2022

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Olympus reviewed the following literature titled "clinical utility of rapid on-site evaluation of touch imprint cytology during cryobiopsy for peripheral pulmonary lesions." with increasing interest in precision medicine for lung cancer, cryobiopsy is expected to improve the success rate not only for histological diagnosis, but also for next-generation sequencing.Rapid on-site evaluation (rose) is an immediate cytological evaluation performed during bronchoscopy.However, little is known about its clinical utility during cryobiopsy.We retrospectively reviewed the data of 63 consecutive patients who underwent cryobiopsy with rose of touch imprint cytology (rose-tic) for solid peripheral pulmonary lesions.When the results of rose-tic of each patient were compared directly with the histological findings of the corresponding specimen, the sensitivity, specificity, and positive and negative predictive values were 69.8%, 90.0%, 93.8%, and 58.1%, respectively.The concordance rate was 76.2%.Therefore, we believe that rose-tic, due to its high specificity and positive predictive value, may be a potential tool in deciding whether cryobiopsy sampling could be finished during bronchoscopy.Mild bleeding 23 patients defined as "blood suctioning required for <1 min." moderate bleeding 35 patients defined as "suctioning required for >1 min; repeat wedging of the bronchoscope for persistent bleeding needed; application of cold saline, diluted vasoactive substance, or thrombin." severe bleeding 1 patient defined as "selective intubation needed for <20 min." postinterventional pneumothorax 1 patient.This literature article requires 3 reports.The related patient identifiers are as follows: (b)(6): bf-p260f.(b)(6): bf-p290.(b)(6): um-s20-17s.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

This supplemental report is being submitted to provided additional information from the author and to provide additional information based on the legal manufacturer's final investigation.New information added to the following fields: b5 and h6.The device history record was unable to be reviewed for this device since no product malfunction was reported.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely the reported event is an accident or a complication associated with a surgical procedure using the subject device.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.

Event Description

Additional information received from the author: in the medical opinion of the author, the olympus device did not cause malfunction nor the adverse events reported.

• 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: 15625323
• MDR Text Key: 301926314
• Report Number: 3002808148-2022-03276
• 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,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2022

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: 09/21/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 10/28/2022
• Supplement Dates FDA Received: 11/23/2022
• 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
• Patient Outcome(s): Other; Required Intervention