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 Problem Pneumothorax (2012)

Event Type  Injury  

Manufacturer Narrative

Olympus medical systems corp.(omsc) received a literature titled ¿pleural dye marking using radial endobronchial ultrasound and virtual bronchoscopy before sublobar pulmonary resection for small peripheral nodules¿.The literature reported the result of the following procedure between april 2016 and june 2017.Video-assisted thoracoscopic wedge resection: 11 cases.Robotic-assisted thoracoscopic surgery: 11 cases.There was a possibility that the above procedures were performed using um-s20-17s and bf-mp60f.The literature reported that 2 patients developed prolonged air leak which caused extension of the hospitalization of the patients for 7 or 8 days.Based on the available information, a direct relationship between the subject devices and the reported adverse events could not be determined.Omsc is submitting four mdrs according to the number of the adverse events.This report is 1 of 4 reports for prolonged air leak (1 of 2) at um-s20-17s.

Event Description

Olympus medical systems corp.(omsc) received a literature titled ¿pleural dye marking using radial endobronchial ultrasound and virtual bronchoscopy before sublobar pulmonary resection for small peripheral nodules¿.The literature reported the result of the following procedure between april 2016 and june 2017.Video-assisted thoracoscopic wedge resection: 11 cases.Robotic-assisted thoracoscopic surgery: 11 cases.There was a possibility that the above procedure was performed using the subject device.In the subject procedures, 2 cases of prolonged air leak occurred.Based on the available information, a direct relationship between the subject device and the reported adverse event could not be determined.Omsc is submitting three mdrs according to the number of the adverse event.This is 1 of 2 reports.

Event Description

Olympus medical systems corp.(omsc) received a literature titled ¿pleural dye marking using radial endobronchial ultrasound and virtual bronchoscopy before sublobar pulmonary resection for small peripheral nodules¿.The literature reported the result of the following procedure between (b)(6) 2016 and (b)(6) 2017.Video-assisted thoracoscopic wedge resection: 11 cases.Robotic-assisted thoracoscopic surgery: 11 cases.There was a possibility that the above procedures were performed using um-s20-17s and bf-mp60.The literature reported that 2 patients developed prolonged air leak which caused extension of the hospitalization of the patients for 7 or 8 days.Based on the available information, a direct relationship between the subject devices and the reported adverse events could not be determined.Omsc is submitting four mdrs according to the number of the adverse events.This report is 1 of 4 reports for prolonged air leak (1 of 2) at um-s20-17s.

Manufacturer Narrative

This is a supplemental report for mfr report #8010047-2020-01779 to correct b5 and h10.The subject device was not been returned to olympus medical systems corp (omsc).Omsc could not review the service and manufacturing record because the serial number was not provided from the facility.The malfunction of the subject device concerning this case has not been reported.The exact cause could not be determined.

• 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
• MDR Report Key: 9833556
• MDR Text Key: 196399963
• Report Number: 8010047-2020-01779
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: K982323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UM-S20-17S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other