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

Model Number	EIC7070-01
Medical Device Problem Codes	Melted (1385); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that during a laryngeal surgery, the coblation wand failed to coagulate and it presented three metal wires fused, the setting used on the controller was ablation: 7; coagulation: 3.The procedure was completed by changing the surgical technique for electrocoagulation for homeostasis, and with a 31-minute surgical delay.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H10 h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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.An analysis of the customer provided images found a coblation wand and an image of the tip with burned electrodes.The root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include activating the device above recommended settings for prolonged periods of time.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: 16812625
• Report Number: 3006524618-2023-00168
• Device Sequence Number: 5780869
• Product Code: GEI
• UDI-Device Identifier: 00817470000443
• UDI-Public: 00817470000443
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2023

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: 10/15/2024
• Device Model Number: EIC7070-01
• Device Catalogue Number: EIC7070-01
• Device Lot Number: 2081294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 04/27/2023; 10/31/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 05/07/2023; 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2021
• 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
• Patient Age: 65 YR
• Patient Sex: Unknown
• Patient Weight: 70 KG