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

Model Number 001-401-161

Device Problem Material Separation (1562)

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

Event Date 08/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation, however, the device history record was reviewed and no non-conformance or reworks were noted during the manufacturing process that relate to the reported issue.No device returned from facility.

Event Description

During a mvr procedure with a hercules 3 universal stabilizer arm, locking mechanism on stabilizer arm broke.When the scrub tech picked up the stabilizer to use, the pieces fell out.No pieces fell into the patient.Patient care was not affected.Patient was on-pump and was heparinized.A backup stabilizer was used and the case was not prolonged.

• 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 Contact: ranjana iyer ; 7555 innovation way; mason, OH 45040 ; 5137555320
• MDR Report Key: 5916227
• MDR Text Key: 53553369
• Report Number: 3003502395-2016-00077
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 001-401-161
• Device Catalogue Number: 001-401-161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 100