MAUDE Adverse Event Report: ATRICURE, INC. ISOLATOR SYNERGY SURGICAL ABLATION SYSTEM OPEN, SHORT JAW; ATRICURE SYNERGY ABLATION SYSTEM

Model Number	OSL2
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4 added udi number for product.G3 updated the "date received by manufacturer" to 12-apr-2024.This date reflects the revised awareness date that led to the reportability decision.
Additional Manufacturer Narrative
The complaint was confirmed. the incorrect expiration date of 2046-10-1 was printed on the tyvek.The correct expiration date of 2026-10-01 was printed on the outer carton.
Event or Problem Description
An osl2 device had a mismatched expiration date between the unit of use and the unit of sale.The expiration date on the unit of sale was correct but the expiration date on the unit of use was incorrect.The device was not used and was replaced with another device to complete the procedure.There was no reported harm to patient or delay or procedure.

• Brand Name: ISOLATOR SYNERGY SURGICAL ABLATION SYSTEM OPEN, SHORT JAW
• Common Device Name: ATRICURE SYNERGY ABLATION SYSTEM
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer (Section G): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: john ehlert ; 7555 innovation way; mason, OH 45040 ; 5136448220
• MDR Report Key: 19205759
• Report Number: 3011706110-2024-00030
• Device Sequence Number: 18160755
• Product Code: OCM
• UDI-Device Identifier: 10840143902192
• UDI-Public: (01)10840143902192(17)461001(10)134783
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2026
• Device Model Number: OSL2
• Device Catalogue Number: A000432
• Device Lot Number: 134783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown