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

Model Number HERCULES UNIVERSAL STABILIZER ARM

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

(b)(4) a device history review and an evaluation for this device could not be done as the product was not returned from the facility.The product exceeded the design life outlined in the ifu.

Event Description

Atricure was contacted by a competitor in regards to broken equipment at a facility.That company had received a phone call from the or manager at the hospital and informed the rep that an estech hercules arm had broken while the surgeon was using it during an mvr.She stated that the surgeon attempted to grab all the pieces out of the patient.The hospital then decided to send the broken arm into a company called ims to be repaired and upon inspection, ims realized that not all the links were present.The hospital ran an x-ray on the patient that revealed that one link had been left in the patient.The rep was informed that at this point, the patient is now too sick to have the link removed surgically but the patient was stable and discharged home.The rep was informed that this arm was put back together by ims and that they had installed a new cable.This information came to atricure via the competitor as they had never sold the facility the device.

• Brand Name: UNIVERSAL STABILIZER ARM, HERCULES 3
• Type of Device: UNIVERSAL STABILIZER ARM, HERCULES 3
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer (Section G): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: anupam bedi
• MDR Report Key: 6661893
• MDR Text Key: 78379499
• Report Number: 3011706110-2017-00056
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: HERCULES UNIVERSAL STABILIZER ARM
• Device Catalogue Number: 001-401-152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/26/2017
• Initial Date FDA Received: 06/22/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability