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U.S. Department of Health and Human Services

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

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ATRICURE, INC. HERCULES UNIVERSAL STABILIZER ARM Back to Search Results
Model Number 401-152
Device Problem Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/09/2015
Event Type  malfunction  
Event Description
It was reported that during set up, the cable broke and the unit fell apart.The product was changed out and surgery was completed successfully and there was no patient harm.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
HERCULES UNIVERSAL STABILIZER ARM
Type of Device
HERCULES UNIVERSAL STABILIZER ARM
Manufacturer (Section D)
ATRICURE, INC.
west chester OH
Manufacturer Contact
john huff
6217 centre park dr.
west chester, OH 45069
04/01/2015
MDR Report Key4755260
MDR Text Key20806723
Report Number3003502395-2015-00012
Device Sequence Number1
Product Code OCL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/01/2015
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 Health Professional
Device Model Number401-152
Device Lot Number71337
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/01/2015
Initial Date FDA Received04/30/2015
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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