MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC PROBE

Model Number UM-S20-17S

Device Problem Break (1069)

Patient Problem Bronchial Hemorrhage (4456)

Event Date 02/17/2021

Event Type  Injury  

Manufacturer Narrative

The device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc will start evaluating the device.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

An endoscopic ultrasonography was performed on a patient with suspected lung cancer using evis lucera bronchofibervideoscope bf-p260f, ultrasonic probe um-s20-17s, and single use guide sheath k-201.Ultrasound endoscopic image was displayed on the monitor at the beginning of the procedure, but then became hard to see.The physician felt the endoscope was caught while withdrawing and bronchostaxis occurred.Ultrasonic probe, a part of the distal tip of um-s20-17s, was partially missing.A fragment which appeared to be the missing part of the probe inside the patient was found by x-ray and was retrieved.The fragment was about 3 cm and looked like stretched plastic.The fragment will not provided to olympus because the hospital will analyze it.The patient was transported to icu for stopping bleeding.The treatment would be successful, according to a doctor at the hospital.According to a nurse at the hospital, no abnormality was noted before the procedure.Multiple doctors set up the devices before the procedure and they felt that the probe was thinner than others.The probe in question was a brand-new and the first use.This report is for um-s20-17s.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The device and single use guide sheath k-201 were returned to olympus medical systems corp.(omsc) for evaluation.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Omsc confirmed the device, and found that a part of the distal tip of the device was partially missing.Omsc confirmed the k-201, and found that there is an indentation on the distal end side.The exact cause was unknown.Omsc surmised that external force when an indentation was generated on the k-201 was also applied to the device, and the internal blade of the device could not be driven normally, so the sheath of the device was twisted and the distal tip of the device fell off.There was the possibility that the patient bleeds because the damaged distal tip of the device touched the patient's body.

• 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: 11490772
• MDR Text Key: 240356699
• Report Number: 8010047-2021-03753
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UM-S20-17S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR