MAUDE Adverse Event Report: ATRICURE, INC. ISOLATOR SYNERGY ACCESS CLAMP

Model Number EMT1

Device Problem Detachment Of Device Component (1104)

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

Event Date 07/15/2016

Event Type  malfunction  

Manufacturer Narrative

Complaint number (b)(4).The device was received and sent to atricure engineering for analysis.The complaint was confirmed.The emt device failed visual inspection, one of the two pins between the jaw link and flex band was missing.The dislodged pin was returned with the emt1 complaint device.The device met all other criteria and functioned normally.The max3 device met all criteria and functioned normally.

Event Description

During operation, "metallic piece" was found in left atria when conducted by emt1 after doing pvi.The surgeon retrieved metal piece, then he/she completed to operation without other issue.At this time, there was no adverse event on the patient.

• Brand Name: ISOLATOR SYNERGY ACCESS CLAMP
• Type of Device: ISOLATOR SYNERGY ACCESS CLAMP
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: ranjana iyer ; 7555 innovation way; mason, OH 45040 ; 5137555320
• MDR Report Key: 5887312
• MDR Text Key: 52499557
• Report Number: 3003502395-2016-00073
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EMT1
• Device Catalogue Number: A000602
• Device Lot Number: 64191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1