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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 Peeled/Delaminated (1454)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/04/2021
Event Type  malfunction  
Manufacturer Narrative
At the olympus service center, the customer¿s issue was not confirmed. The scope passed the leak test. Other issues were found. The bending section cover glue was cracked. The forceps cover glue was peeling. The scope connector was loose, and the customer label had corrosion. The investigation is ongoing. A supplemental report will be submitted upon completion of the investigation.
 
Event Description
It was reported by the customer, the evis exera ii ultrasound gastrovideoscope had a leak at the distal tip. No patient harm reported. During the evaluation of the device, it was noted the forceps cover glue was peeling. This report is to capture the reportable malfunction of peeling forceps cover glue noted at estimation.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation. A review of the device history record found no deviations that could have caused or contributed to the reported issue. It has been over 5 years since the subject device was manufactured. Based on the results of the legal manufacturer's investigation, the root cause of the forceps cover glue peeling could not be identified. However, it is possible the cause was related to some kind of external force that was applied to the relevant part. Per the instructions for use: -inspect the external surface of the entire insertion section including the bending section and the distal end for dents, bulges, swelling, scratches, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities. Olympus will continue to monitor field performance for this device.
 
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Brand NameEVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
Type of DeviceULTRASOUND 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 Key12932860
MDR Text Key285924702
Report Number8010047-2021-15575
Device Sequence Number1
Product Code ODG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093395
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGF-UCT180
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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