MAUDE Adverse Event Report: ATRICURE, INC. HERCULES UNIVERSAL STABILIZER ARM

Model Number 001-401-152

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/12/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4) upon receipt, the hercules device, lot number 10223, released for sale in 2009, was visually and functionally inspected pursuant to specific atricure investigation procedures.The quick connect mechanism was missing from device.All links of the device were still attached by the cable.

Event Description

A patient underwent a undetermined surgical procedure on (b)(6) 2022.As the hercules ii arm was being tightened, the staff felt and heard a snap.The surgical team noticed that pieces from the hercules arm fell into the patient¿s chest.The links were removed from patient manually and an x-ray was completed to confirm all parts had been removed.Upon evaluation of the device by atricure, it was determined that the quick connect mechanism had separated from the device.This was a device malfunction and no patient adverse event was reported.

• Brand Name: HERCULES UNIVERSAL STABILIZER ARM
• Type of Device: HERCULES UNIVERSAL STABILIZER ARM
• 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: 15390525
• MDR Text Key: 306015482
• Report Number: 3011706110-2022-00033
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 001-401-152
• Device Catalogue Number: 001-401-152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2022
• Date Manufacturer Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention