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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. UM-G20-29R ULTRASONIC PROBE Back to Search Results
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.
 
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Brand NameUM-G20-29R ULTRASONIC PROBE
Type of DeviceULTRASONIC PROBE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
MDR Report Key7595111
MDR Text Key111838172
Report Number8010047-2018-01124
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received06/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUM-G20-29R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/18/2018
Is This a Reprocessed and Reused Single-Use Device? No

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