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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE Back to Search Results
Model Number GF-UCT180
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The device was evaluated at ode.As a result of the evaluation, the following was confirmed.The coating on the insertion tube was peeled off.The electrical connector and ultrasonic cable connector were dirty.There was no radius of the forceps elevator wire.The device was last repaired on (b)(6) 2021.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 inspected the device at the service department of olympus (b)(4) and found that there was a gap in the adhesive on the distal end due to the deterioration of the adhesive due to the chemical stress applied during the reprocessing.There was no report of patient injury associated with the event.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information.From the information provided, olympus medical systems corp.(omsc) confirmed that the adhesive around the acoustic lens surface at the distal end was peeled off.Since the device was manufactured on october 5, 2017, it is highly unlikely that the adhesive would come off due to aging.Therefore, it is possible that the reported event occurred due to the application of an external force, such as strong rubbing around the acoustic lens surface, during normal use, including reprocessing.The instruction manual states that an inspection of the external surface of the entire insertion section including the bending section and the distal end, should be performed.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.If additional information becomes available, this report will be supplemented.
 
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Brand Name
EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
Type of Device
ULTRASOUND GASTROVIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key12323371
MDR Text Key266667970
Report Number8010047-2021-10275
Device Sequence Number1
Product Code ODG
UDI-Device Identifier04953170356346
UDI-Public04953170356346
Combination Product (y/n)N
PMA/PMN Number
K093395
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/04/2021
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 No Information
Device Model NumberGF-UCT180
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/28/2021
Initial Date FDA Received08/16/2021
Supplement Dates Manufacturer Received09/15/2021
Supplement Dates FDA Received10/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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