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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number GIF-HQ190
Device Problems Activation, Positioning or SeparationProblem (2906); Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/02/2019
Event Type  Malfunction  
Event Description

Nurse was asked to check gif-hq190 gastroscope when scope reprocessing technician could not pass a brush through the scope. While trying to pass the brush through the endoscope, a metal clip used in endoscopy procedures was dislodged from the scope. Earlier in the day, the scope reprocessing technician had the same experience on the same gastroscope where she could not pass the brush through. She suctioned fluid through the endoscope trying to break up what was causing the blockage. On the next attempt to brush the scope, the brush did pass through. The technician continued cleaning the scope following manufacturer's instructions (high level disinfection). The nurse, concerned that the endoscope was used with a retained clip in it (knowing that this issue with passing the brush through the same endoscope occurred earlier in the day and knowing that a clip was dislodged from the scope during the second cleaning), did an investigation to determine when that scope was used to deploy clips. The scope was used in a 0730 egd procedure that same day where the physician reported clips being used and "two clips did not deploy properly. " the clips used are manufactured by boston scientific.

 
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Brand NameEVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Type of DeviceCOLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2400 ringwood ave
san jose CA 95131
MDR Report Key9665429
MDR Text Key177644089
Report Number9665429
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 12/03/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/04/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberGIF-HQ190
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/03/2019
Event Location Hospital
Date Report TO Manufacturer02/04/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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