MAUDE Adverse Event Report: ARTHROCARE CORPORATION PROCISE XP COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	EIC8872-01
Medical Device Problem Codes	Circuit Failure (1089); Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during set up, the procise coblator wand had a circuit failure and the wand sparked.There was a back up device available and no surgical delay was reported.No patient involvement was reported.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.A visual inspection revealed that the returned instrument showed no manufacturing abnormalities.Fluid was in the fluid line.Electrodes had been used and bio debris was present.The wand was bent from use.There were no signs of arcing between the spacer and metal tube.Product was out of the original packaging.No packaging returned.A functional evaluation was performed on the returned device and found the opened device, which was tested and plugged into the controller and registered settings (7,3).The wand was able to generate plasma and coagulation as intended.There were no sparks or arcing observed during functional testing.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 failures and/or harms were documented appropriately, and there were no indications to suggest the anticipated risks are not adequate.The root cause could not be determined since the reported malfunctions could not be duplicated during the investigation.Factors that can contribute to the reported events include a possible spark from the electrodes when they come into contact with a conductive medium such as saline.No containment or corrective actions are recommended at this time.

• Brand Name: PROCISE XP 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: 18566445
• Report Number: 3006524618-2024-00031
• Device Sequence Number: 15156173
• Product Code: GEI
• UDI-Device Identifier: 00817470000368
• UDI-Public: 00817470000368
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2026
• Device Catalogue Number: EIC8872-01
• Device Lot Number: 2116776
• 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: 01/02/2024
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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