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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHROCARE CORPORATION FA QUANTUM 2 CONTROLLER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

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ARTHROCARE CORPORATION FA QUANTUM 2 CONTROLLER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Catalog Number 28168
Device Problem Arcing (2583)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/16/2023
Event Type  malfunction  
Event Description
It was reported that during an unknown procedure, the left connector of the quantum 2 controller was black from arcing.The procedure was completed with a smith and nephew back up device with no surgical delay.No further complications were reported.
 
Manufacturer Narrative
H10: internal complaint reference number: (b)(4).
 
Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection revealed the 18pin port (which is on the right side) has heavy arc/burn damage to it.The warranty seal is broken.A functional evaluation was performed on the returned device and found the 18pin port was not tested due to its damaged.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause has been associated with a component failure.Factors that could have contributed to the failure include there may be a wand detection circuit failure, damaged receptacle, plugging in a wet wand connector, or exposure of saline to the wand receptacle.No containment or corrective actions are recommended at this time.
 
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Brand Name
FA QUANTUM 2 CONTROLLER
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
ARTHROCARE CORPORATION
7000 west william cannon drive
austin TX 78735
Manufacturer (Section G)
ARTHROCARE CORPORATION
7000 west william cannon drive
austin TX 78735
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key18105143
MDR Text Key327777639
Report Number3006524618-2023-00423
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082666
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/19/2024
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 Catalogue Number28168
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/02/2023
Initial Date FDA Received11/09/2023
Supplement Dates Manufacturer Received02/14/2024
Supplement Dates FDA Received02/19/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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