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

Model Number	UM-S20-20R-3
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned to olympus medical systems corp.(omsc) yet.Omsc will investigate the subject device to identify the root cause of this failure phenomenon upon receipt of it.The exact cause of the reported event could not be conclusively determined at this time.There were no further details provided.If significant additional information is received, this report will be supplemented.
Event or Problem Description
During a bronchoscopy, the distal end of the device fell off into the patient's cavity.The user retrieved the distal end from the patient's cavity.The user replaced the subject device with a similar device and completed the procedure.There was no report of the patient¿s injury regarding this event.
Additional Manufacturer Narrative
Omsc investigated the subject um-s20-20r and found the following.Insertion tube got broken.A part of the surface of the broken tube looked like riped down.The surface of the broken tube had a flat part.Omsc surmised as the following.The flat part of the broken surface was made by contact with a sharp object such as endo therapy.As the user repeatedly pushed and pulled the subject device forcefully, this notch was getting widened.And finally, the distal end of the insertion part was ripped down.The instruction manual of the subject um-s20-20r states as the following.Carefully insert the ultrasonic probe using slow.Careless insertion of the ultrasonic probe can damage to the patient and/or the probe.Manipulate the ultrasonic probe slowly and carefully when the endoscope is sharply angled or the forceps elevator is raised.Forcefully pushing or pulling the ultrasonic probe may damage it.The device history record indicates that the subject device has been shipped in conformity to the specifications.There were no further details provided.If significant additional information is received, this report will be supplemented.

• Brand Name: ULTRASONIC PROBE
• Common Device Name: 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: 8973952
• Report Number: 8010047-2019-03225
• Device Sequence Number: 16219583
• Product Code: ITX
• UDI-Device Identifier: 04953170368592
• UDI-Public: 04953170368592
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K001203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: UM-S20-20R-3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 10/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1