EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-HQ190

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-04 for EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-HQ190 manufactured by Olympus Medical Systems Corp..

Event Text Entries

[177644089] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9665429
• MDR Report Key: 9665429
• Date Received: 2020-02-04
• Date of Report: 2019-12-03
• Date of Event: 2019-12-02
• Report Date: 2019-12-03
• Date Reported to FDA: 2019-12-03
• Date Reported to Mfgr: 2020-02-04
• Date Added to Maude: 2020-02-04
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Generic Name: COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Product Code: FAJ
• Date Received: 2020-02-04
• Model Number: GIF-HQ190
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: OLYMPUS MEDICAL SYSTEMS CORP.
• Manufacturer Address: 2400 RINGWOOD AVE SAN JOSE CA 95131 US 95131

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-02-04