MAUDE Adverse Event Report: ATRICURE INC. UNIVERSAL STABILIZER ARM, HERCULES 3; HERCULES 3 UNIVERSAL STABILIZER ARM

Model Number HERCULES

Device Problems Break (1069); Material Frayed (1262)

Patient Problem Not Applicable (3189)

Event Date 01/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the devices were returned for evaluation and visually and functionally tested pursuant to qrf-0371.A.The complaint was confirmed upon receipt of the device.The cable has broken and started to fray.Cables are susceptible to failure if the device is not maintained and utilized per the product's instructions.

Event Description

Sterile processing assistant at hospital stated that two hercules retractors were broken and that they cannot be used in surgery.It was stated that the cable on both of the devices were severed and frayed.It looks as if they could have been tightened until the cable snapped.

• Brand Name: UNIVERSAL STABILIZER ARM, HERCULES 3
• Type of Device: HERCULES 3 UNIVERSAL STABILIZER ARM
• 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: 6286900
• MDR Text Key: 66071832
• Report Number: 3003502395-2017-00018
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLASS I
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2017

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: Other
• Device Expiration Date: 08/01/2020
• Device Model Number: HERCULES
• Device Catalogue Number: 001-401-161
• Device Lot Number: 72413 , 72458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/03/2017
• Initial Date FDA Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1