MAUDE Adverse Event Report: ARTHROCARE CORPORATION EVAC 70 XTRA COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EICA5872-01
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a tonsillectomy, the evac 70 xtra began to get clogged and charred at the end, the staff attempted to clean the char off when it began to spark.The procedure was completed with non-significant delay using a smith and nephew back up device.No further complications were reported.
Event or Problem Description
It was reported that during a tonsillectomy, the evac 70 xtra got clogged and charred at the end, the wand was taken off the patient and attempted to clean the char off when it began to spark.The procedure was completed with a 5 minute delay using a smith and nephew back up device.No further complications were reported.
Additional Manufacturer Narrative
The reported device was received for evaluation.A visual inspection revealed no manufacturing abnormalities.Product was out of the original packaging.No packaging returned.Bio debris is in the suction opening of the tip and under the electrodes.Fluid is in the fluid lines.A functional evaluation was performed on the returned device and found the opened device was tested and plugged into the controller and registered settings (7,3).Coagulation and plasma were generated as intended.Minimum saline was drawn with maximum effort through a syringe multiple times.The fluid line did not clear for easy suction.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found 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 unintended use of the device.Factors that could have contributed to the failure include: 1) the tissue attempted to be suctioned was too large, thereby causing a clog.2) insufficient suction pressure or saline flow to excavate tissue.No containment or corrective actions are recommended at this time.

• Brand Name: EVAC 70 XTRA COBLATOR II
• Common Device Name: 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 Key: 17071045
• Report Number: 3006524618-2023-00236
• Device Sequence Number: 17836581
• Product Code: GEI
• UDI-Device Identifier: 00817470003710
• UDI-Public: 00817470003710
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K202006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/26/2026
• Device Model Number: EICA5872-01
• Device Catalogue Number: EICA5872-01
• Device Lot Number: 2112283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown