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

Model Number EMT1

Device Problem Mechanical Problem (1384)

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

Event Date 12/10/2016

Event Type  malfunction  

Manufacturer Narrative

Case- (b)(4).The lot with nonconforming devices, 65863, was manufactured on 6/21/2016 prior to the implementation of the inspection or the welding procedure.The malfunction was found during a 100% inspection of devices that were returned from japan as part of a volunteer inventory swap.

Event Description

Rework routers ((b)(4)) were used to open and inspect all five lots of emt1s that were returned from cmi per (b)(4).The inspections were completed on december 10, 2016.(b)(4) identified seven devices that did not meet the sort criteria, one of which had a dislodged proximal jaw drive subassembly pin.The pin dislodged during unpacking.This is documented on (b)(4).No patient involvement.

• 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 ; 5137555328
• MDR Report Key: 6232150
• MDR Text Key: 64128486
• Report Number: 3003502395-2017-00001
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/10/2016

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
• Device Operator: Biomedical Engineer
• Device Expiration Date: 11/21/2016
• Device Model Number: EMT1
• Device Catalogue Number: A000602
• Device Lot Number: 65863
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2016
• Initial Date FDA Received: 01/08/2017
• 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