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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 Material Split, Cut or Torn (4008)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to the olympus (b)(4) incorporation for evaluation. The control body of the was found to have a gap at the distal end. In addition there was a cut on the probe of the scope. The most likely cause for the reported event is mishandling. The instruction manual states "do not strike, hit, or drop the endoscope's distal end, insertion tube, bending section, control section, universal cord, or endoscope connector. Also, do not bend, pull, or twist the endoscope's distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force. The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations. It could also cause parts of the endoscope to fall off inside the patient. ".
 
Event Description
This is an asset return which was found to have a reportable malfunction during estimation. There was no other device issue or patient injury reported.
 
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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 Key11089439
MDR Text Key224152902
Report Number8010047-2020-11081
Device Sequence Number1
Product Code ODG
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K093395
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2020
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 Manufacturer11/27/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/14/2013
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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