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

Catalog Number EIC5874-01

Device Problem Arcing (2583)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference number:(b)(4).

Event Description

It was reported that the evac xtra coblator wand presented arcing due to the separation between the electrode tip and the shaft.The deficiency was observed while performing the investigation for the device; therefore, there was no patient involvement.

Manufacturer Narrative

H10: h3, h6: the reported device was received for evaluation.A visual inspection the returned instrument shows no manufacturing abnormalities.Fluid is in the fluid lines.Electrodes have been used.Bio debris is present.The wand is bent from use.The black shrink wrap is deformed at the distal edge.There is separation between the electrode tip and the shaft.Product was out of the original packaging.No packaging returned.A functional evaluation found plasma is arching at the separation of the tip and shaft.Saline is leaking from under the black shrink wrap at the distal edge.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 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 was associated with unintended use of the device.Factors that could have contributed to the reported event include insufficient suction pressure or saline flow to excavate tissue.No containment or corrective actions are recommended at this time.

• Brand Name: EVAC 70 XTRA HP COBLATOR II
• 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 Key: 18199096
• MDR Text Key: 329209432
• Report Number: 3006524618-2023-00458
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K202006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

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 Number: EIC5874-01
• Device Lot Number: 2104574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/23/2023
• Supplement Dates Manufacturer Received: 02/07/2024
• Supplement Dates FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1