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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 Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The returned device was evaluated by olympus and it was determined a gap of adhesive on the distal end was present. The problem was attributed to a shock, caused by dropping and knocking the endoscope to a hard surface or object (handling).
 
Event Description
A user facility returned to olympus for repair a scope that failed the leak test in their medivator. The problem, as reported to olympus, was found during reprocessing. Upon evaluation of the returned device, it was noted that the forceps cover glue was peeling. There was no patient injury or harm, associated with the problems, reported to olympus.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer¿s final investigation. Based on the legal manufacturer¿s investigation, the device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device that would cause or contribute to the reported issue. The device met all specifications at the time of shipment. The instructions for use states: ultrasound gastrovideoscope gf-uct180. Chapter 3 preparation and inspection. 3. 2 inspection of the endoscope. 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.
 
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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 Key11270249
MDR Text Key243691448
Report Number8010047-2021-02149
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 user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2021
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 Manufacturer01/06/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/06/2017
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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