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

Model Number	EICA8872-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that during a tonsillectomy, the surgeon noticed that the procise xp coblator ii wand was no longer working, thus, the surgeon inspected the tip with a magnifying surgical lops and stated that the middle coil/wire was missing.It was stated that the piece was left inside of the patient.Non-significant delay was reported, and the procedure was finished with a smith and nephew back up device.No further complications were reported.
Additional Manufacturer Narrative
H10 h3,h6: the reported device was received for evaluation.Visual inspection observed the returned instrument shows no manufacturing abnormalities.Fluid is in the fluid line.Electrodes have been heavily used.One electrode has eroded into two pieces.Bio debris is present.The wand is bent from use.Product was out of the original packaging.No packaging returned.A functional evaluation showed the opened device was tested and plugged into the controller and registered settings (7,3).The wand produced plasma and coagulation as expected.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.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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.A clinical review states based on the information provided no clinical factors were found which would have contributed to the reported breakage.The wand is an externally communicating device, it is neither manufactured nor intended for implantation.It is also not approved for long term internal tissue exposure and long-term implantation data is not available.The patient impact beyond the reported device breakage and retained foreign body could not be definitively determined.Micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.The root cause has been associated with unintended use of the device.Factors that could have contributed to the reported event include: (1) hitting the device tip against a hard surface.(2) using the device as a lever to enlarge surgical site.(3) mechanical displacement of tissue through applied force.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: 17031654
• Report Number: 3006524618-2023-00220
• Device Sequence Number: 17885832
• Product Code: GEI
• UDI-Device Identifier: 00817470003727
• UDI-Public: 00817470003727
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/21/2025
• Device Model Number: EICA8872-01
• Device Catalogue Number: EICA8872-01
• Device Lot Number: 2109159
• 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: 05/10/2023
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown