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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRICURE, INC. UNIVERSAL STABILIZER ARM, HERCULES 3
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ATRICURE, INC. UNIVERSAL STABILIZER ARM, HERCULES 3 Back to Search Results
Model Number 001-401-161
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device was returned and evaluated.The complaint was confirmed and an investigation of the lock plate failure is being initiated.
 
Event Description
The 3rd party distributor stated that a facility notified them that just after the sterilization process, the hercules 3 baseplates were found broken.This was within the one year warranty timeframe.This malfunction did not occur during a procedure, there was no patient harm.
 
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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 Key7108475
MDR Text Key94954645
Report Number3011706110-2017-00103
Device Sequence Number1
Product Code DWS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
D233474
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/12/2017
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 Model Number001-401-161
Device Catalogue Number001-401-161
Device Lot Number72580
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/14/2017
Initial Date FDA Received12/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/16/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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