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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 Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/15/2018
Event Type  malfunction  
Manufacturer Narrative
Case-(b)(4).The device has not been returned but is anticipated; once additional information is received, a supplemental will be submitted.
 
Event Description
On (b)(6) 2018 it was reported that there was an incident where the hercules arm broke after a surgical procedure as soon as it was handed to the scrub nurse.There was no issue with the device the entire time while in use during procedure.
 
Manufacturer Narrative
(b)(4).Device for lot#70728 (reusable)was returned for evaluation and visually and functionally tested.The complaint was confirmed upon receipt of the product.The proximal end of the cable had detached from the handle.
 
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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
MDR Report Key7607345
MDR Text Key111868737
Report Number3011706110-2018-00173
Device Sequence Number1
Product Code DWS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2018
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 Number70728
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2018
Date Manufacturer Received05/15/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age75 YR
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