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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 Date 11/14/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4): the device was returned and evaluated.The complaint was confirmed.Further investigation is being performed for this device malfunction.There was no reported patient involvement.
 
Event Description
On (b)(6) 2017, a surgeon identified that the retaining mechanism near the spring broke on a hercules 3 universal stabilizer arm prior to use.The device malfunction was reported to an atricure representative on 11/15/2017.There is no reported patient involvement.
 
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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 Key7110410
MDR Text Key95075519
Report Number3011706110-2017-00105
Device Sequence Number1
Product Code DWS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
D233474
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
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 Health Care Professional
Device Model Number001-401-161
Device Catalogue Number001-401-161
Device Lot Number74886
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/15/2017
Initial Date FDA Received12/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/11/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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