MAUDE Adverse Event Report: OLYMPUS DEVISE QUICKCLIP PRO

Catalog Number HX-202UR

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Failure to Form Staple (2579)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/20/2017

Event Type  Injury  

Event Description

Egd performed on patient with active upper gi bleeding.An ulcer identified and a quickclip pro was used to clip the vessel, but it fell off after deployment.The y clip did not close properly.The ulcer began to bleed when the y clip fell off.Gold probe cautery was attempted to stop bleeding, but was unsuccessful.Patient had embolization procedure by interventional radiologist to top the bleeding of the vessel.

• Brand Name: DEVISE QUICKCLIP PRO
• Type of Device: DEVISE QUICKCLIP PRO
• Manufacturer (Section D): OLYMPUS; 3500 corporate pkwy. ; po box 610; center valley PA 18034 0610
• MDR Report Key: 7201172
• MDR Text Key: 97636771
• Report Number: 7201172
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HX-202UR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 85