MAUDE Adverse Event Report: ATRICURE, INC. UNIVERSAL STABILIZER ARM, HERCULES 2

Model Number 401-152L

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the hercules retractor arm device was not returned for evaluation, but a device history review was obtained for lot number 70031.There is nothing in the device history record that would indicate that the devices were released with any non-conformances that would contribute to the complaint.

Event Description

It was reported that on (b)(6) 2020 a (b)(6) female patient underwent an on-pump heparinized mitral valve repair, maze, left atrial appendage management procedure.During the procedure the surgeon was using a re-usable retractor device, as he tightened the knob to lock the retractor arm in place, the internal wire came loose from the assembly and the arm lost its rigidity.The surgeon then attempted to remove the retractor and the wire and segments came free from the assembly and several of the segments slipped off the wire and fell into the surgical site.The surgeon retrieved the segments that were immediately visible, and a back-up retractor arm was used then to complete the procedure.Post-surgery patient had an x-ray study which confirmed that no segments were left behind inside the patient.The procedure was prolonged for 20min, there was no injury to the patient.

Manufacturer Narrative

(b)(4) the hercules 2 stabilizer arm device lot number 70031 was returned for evaluation and visually and functionally tested.The complaint was confirmed for a broken cable.

• Brand Name: UNIVERSAL STABILIZER ARM, HERCULES 2
• Type of Device: UNIVERSAL STABILIZER ARM, HERCULES 2
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• MDR Report Key: 10492921
• MDR Text Key: 207931514
• Report Number: 3011706110-2020-00029
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• PMA/PMN Number: D233474
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 401-152L
• Device Catalogue Number: 401-152L
• Device Lot Number: 70031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLL2,ACH2,3011 CRYO,3015 CRYO
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 117