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

Model Number A1603

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/13/2019

Event Type  malfunction  

Event 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
• Type of Device: CLIP, VASCULAR
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORPORATION; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9271446
• MDR Text Key: 164848238
• Report Number: 9271446
• Device Sequence Number: 1
• Product Code: DSS
• UDI-Device Identifier: 00607915110581
• UDI-Public: (01)00607915110581(17)540602(30)01(10)1357103
• 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: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: A1603
• Device Catalogue Number: A1603
• Device Lot Number: 1357103
• 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: 10/23/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20805 DA