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

Catalog Number	EIC8872-01
Medical Device Problem Codes	Overheating of Device (1437); Arcing (2583); Intermittent Energy Output (4025)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during tonsillectomy + adenoidectomy procedure, the procise xp wand had an electrical spark and overheated.Surgery was completed with a competitor device, instead.There was no surgical delay, and no further complications were reported.Patient status is good.
Additional Manufacturer Narrative
H10: internal complaint reference: case-2024-00216915-1.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.A visual inspection revealed no manufacturing abnormalities.Fluid is in the fluid line.The electrodes have been heavily used causing one electrode to erode.Bio debris is present.The wand is bent from use.Product was out of the original packaging.No packaging returned.A functional evaluation was performed on the returned device and found settings (7,3).Coagulation and plasma were generated intermittently with the available electrode pieces.No sparks or arcing were observed.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 has been associated with a component failure.Factors that could have contributed to the failure include a broken the wire inside the wand cable or a damaged wire between the transition of the handle and the shaft.Based on this investigation, the need for corrective action is not indicated.

• 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: 19987865
• Report Number: 3006524618-2024-00319
• Device Sequence Number: 8585834
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

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: 10/04/2026
• Device Catalogue Number: EIC8872-01
• Device Lot Number: 2134376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2023
• 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