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

Model Number	EIC7070-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an ent procedure, the tip of the coblation wand fell off and got stuck into the patient's tissue.The piece was removed eventually by using tweezers.The procedure was completed without delay using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
The reported device was received for evaluation.Visual inspection observed the returned instrument shows no manufacturing abnormalities.Fluid is in the fluid line.The electrode has been heavily used and worn off of the tip of the wand.Bio debris is present.The wand is bent from use.The black shrink wrap is deformed at the distal edge.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).A functional test for plasma could not be performed due to the electrode being worn off the wand.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.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 undated photos of the device were provided for review and confirms the reported breakage.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 LW 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: 16743410
• Report Number: 3006524618-2023-00135
• Device Sequence Number: 5435039
• Product Code: GEI
• UDI-Device Identifier: 00817470000443
• UDI-Public: 00817470000443
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2023

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: 12/04/2024
• Device Model Number: EIC7070-01
• Device Catalogue Number: EIC7070-01
• Device Lot Number: 2084253
• 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: 03/25/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2021
• 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: Required Intervention
• Patient Sex: Unknown