MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. UM-G20-29R ULTRASONIC PROBE

Model Number UM-G20-29R

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to omsc for evaluation.As the evaluation is in progress, the exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that during intraductal ultrasonography (idus), when the subject device was inserted along the guide wire, the distal end of the subject device was detached from the subject device and fell in the patient.Since the guide wire was inserted into the fallen part, the distal end could be retrieved from the patient along with the guide wire.The idus was cancelled since there was no spare device at the user facility.Originally, the idus was not main procedure for the patient, but ancillary procedure of another procedure.There was no patient injury report associated with this event.The subject device was brand new.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation result.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The evaluation of the subject device by omsc confirmed that the guidewire port was torn.Based on the analysis of the fracture surface, the guidewire port possibly tore off due to an external physical force.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.The instruction of the subject device warns; when inserting the guidewire into the ultrasonic probe, hold it close to the guidewire port and carefully insert it using slow, short strokes.Otherwise, damage to the ultrasonic probe can result.The exact cause of the reported event could not be conclusively determined.

• Brand Name: UM-G20-29R ULTRASONIC PROBE
• Type of Device: ULTRASONIC PROBE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7595111
• MDR Text Key: 111838172
• Report Number: 8010047-2018-01124
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/18/2018

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
• Device Operator: Health Professional
• Device Model Number: UM-G20-29R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/13/2018
• Supplement Dates Manufacturer Received: 06/18/2018
• Supplement Dates FDA Received: 07/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1