MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORPORATION STEALTH® SPRING CLIP; CLIP, VASCULAR

Model Number	A1603
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A disposable vascular clamp that is used for internal mammary grafts on cabg patients failed.Defective lot? this has happened multiple times before.This time we were able to locate the lot number.A new one was obtained.

• Brand Name: STEALTH® SPRING CLIP
• Common Device Name: CLIP, VASCULAR
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORPORATION; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9271446
• Report Number: 9271446
• Device Sequence Number: 3671558
• Product Code: DSS
• UDI-Device Identifier: 00607915110581
• UDI-Public: (01)00607915110581(17)540602(30)01(10)1357103
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/23/2019
• Report Date (Section F): 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: A1603
• Device Catalogue Number: A1603
• Device Lot Number: 1357103
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2019
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/23/2019