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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC GASTROVIDEOSCOPE
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OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC GASTROVIDEOSCOPE Back to Search Results
Model Number GF-UE160-AL5
Device Problem Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
During a yearly preventative maintenance of the ultrasonic gastrovideoscope, an olympus field service engineer discovered that the acoustic lens protection on the distal end of the scope was missing.There was no patient involvement, no harm or user injury reported due to the event.
 
Manufacturer Narrative
Olympus is not aware of how long the scope has been used without the acoustic lens protection.The customer was advised that it is not safe to use the scope and an informative offer of the cost to repair the scope was sent.The device has not been received to date.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.
 
Event Description
During a yearly preventative maintenance of the ultrasonic gastrovideoscope, an olympus field service engineer discovered that the acoustic lens protection on the distal end of the scope was missing.There was no patient involvement, no harm or user injury reported due to the event.
 
Manufacturer Narrative
Olympus is not aware of how long the scope has been used without the acoustic lens protection.The customer was advised that it is not safe to use the scope and an informative offer of the cost to repair the scope was sent.The device has not been received to date.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct information provided on the initial report.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the yearly preventative inspection of customer equipment, the surface of the acoustic lens was found damaged.Damages were observed in the distal end.Therefore, it was possible that external force was applied to the distal end.The following information were also obtained from the investigation: · insertion tube is deformed · video cable is deformed · the product met its standards at the time it was shipped the instruction manual identifies the following related verbiage which could have prevented the phenomenon: ¿ do not apply shock to the distal end of the insertion section, particularly the ultrasound transducer and the objective lens surface at the distal end.Visual abnormalities may result.¿ olympus will continue to monitor field performance for this device.
 
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Brand Name
ULTRASONIC GASTROVIDEOSCOPE
Type of Device
ULTRASONIC GASTROVIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key13122684
MDR Text Key285189133
Report Number8010047-2021-17003
Device Sequence Number1
Product Code ODG
UDI-Device Identifier04953170356261
UDI-Public04953170356261
Combination Product (y/n)N
Reporter Country CodeSI
PMA/PMN Number
K051541
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberGF-UE160-AL5
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/09/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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