MAUDE Adverse Event Report: ATRICURE, INC. UNIVERSAL STABILIZER ARM, HERCULES; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number 401-152L

Device Problems Break (1069); Leak/Splash (1354); Noise, Audible (3273)

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

Event Date 08/12/2020

Event Type  malfunction  

Event Description

Md was tightening the handle of the retractor when a "pop" was heard.The retractor seemed to work fine at first until the handle was one more time.At this time the retractor fell apart spilling multiple metal"balls" (approximately 1 inch in diameter) into the chest.Md immediately removed the remaining retractor from the chest and all of the "balls" that were visible.

• Brand Name: UNIVERSAL STABILIZER ARM, HERCULES
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• MDR Report Key: 10683021
• MDR Text Key: 211453837
• Report Number: 10683021
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 401-152L
• Device Catalogue Number: AES 520
• Device Lot Number: 70031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Weight: 113