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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.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The following sections were updated: g4, g7, h2, h4, h6, h10.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the probable cause of the damage is likely an external force was applied to the acoustic lens damaging it and resulting in scratches.There was also additional damage observed to the curved part, which was likely due to an external force being applied.It is also possible the amount of use and age of the device (over 7 yeas) may have led to degradation, as well.The instructions for use (ifu) states: "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 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 Key11089439
MDR Text Key224152902
Report Number8010047-2020-11081
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 02/01/2021
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 Health Professional
Device Model NumberGF-UCT180
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/30/2020
Initial Date FDA Received12/29/2020
Supplement Dates Manufacturer Received01/25/2021
Supplement Dates FDA Received02/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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