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

Model Number GIF-HQ190

Device Problems Activation, Positioning or Separation Problem (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.

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Type of Device: COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2400 ringwood ave; san jose CA 95131
• MDR Report Key: 9665429
• MDR Text Key: 177644089
• Report Number: 9665429
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: GIF-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 FDA: 12/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15330 DA