MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. QUICKCLIP PRO; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number	HX-202UR
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Quick clip pro acted as if it worked during the procedure but the clip itself would not release from the device.Fda safety report id# (b)(4).

• Brand Name: QUICKCLIP PRO
• Common Device Name: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP. ; tokyo 192-8 507; JA 192-8507
• MDR Report Key: 9543300
• Report Number: MW5092011
• Device Sequence Number: 2833934
• Product Code: PKL
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 12/31/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: HX-202UR
• Device Lot Number: 9JC067
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR