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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE Back to Search Results
Model Number GIF-Q180
Device Problem Mechanical Problem (1384)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus for evaluation.The device was visually inspected and frayed wires were found at the distal sheath.This has been determined to be a reportable malfunction.The cause cannot be determined at this time.If additional information becomes available at a later time, this report will be supplemented.
 
Event Description
It was reported that during maintenance the handle of the scope was loose.
 
Manufacturer Narrative
This report is being supplemented to provide additional information (h10) and corrected data (h10) regarding the reported event.After further investigation of the event it was determined the reported malfunction does not meet the definition of a reportable malfunction and was reported in error.No further reporting is required.
 
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Brand Name
EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
Type of Device
GASTROINTESTINAL VIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key10353899
MDR Text Key224633216
Report Number8010047-2020-05112
Device Sequence Number1
Product Code FDS
Combination Product (y/n)N
PMA/PMN Number
K100584
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/14/2020
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 NumberGIF-Q180
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/20/2020
Initial Date FDA Received07/31/2020
Supplement Dates Manufacturer Received08/21/2020
Supplement Dates FDA Received09/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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