MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES APPLIED MEDICAL RESOURCES; CLIP, VASCULAR

Model Number A1704

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2016

Event Type  No Answer Provided  

Event Description

Avid medical is the manufacturer of a custom procedure tray that contains the following medical device: clips, spring surgical stealth, part no.A1704 supplied by (b)(4).Avid medical received a complaint on 11/30/2016 originated by (b)(6) stating that during the case the clips repeatedly flew off the end of patient¿s vein each time they tried to dilate, not seeming to perform up to the standard needed to do the surgery.The complained clip was not available for evaluation.Avid medical issued formal complaint (b)(4) to the supplier for non- functioning clips from manufacturer lot no.1184100.No patient injury was reported.

• Brand Name: APPLIED MEDICAL RESOURCES
• Type of Device: CLIP, VASCULAR
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: sharon moll ; 9000 westmont dr.; toano, VA 23168
• MDR Report Key: 6196506
• MDR Text Key: 63327799
• Report Number: 1047429-2016-00021
• Device Sequence Number: 1
• Product Code: DSS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A1704
• Device Lot Number: 1184100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1