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

Catalog Number	EIC8875-01
Medical Device Problem Codes	Break (1069); Degraded (1153); Overheating of Device (1437); Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an ent surgery, the procise wand emitted sparks, tip of the wand seems to be broken as per the picture provided.The procedure was successfully completed using a back-up device.There was a surgical delay less than 30 minutes and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).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 used.Bio debris is present.There is evidence of arcing between the spacer and metal tube.The spacer has melted on one side exposing the electrode legs.The metal tube is burnt and eroded.Product was out of the original packaging.No packaging returned.A functional evaluation showed the device was plugged into the controller and registered settings (7,3).The wand was able to generate plasma and coagulation.There was arcing between the spacer and shaft.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 unintended use of the device.Factors that could have contributed to the failure include 1) used non-conductive media.2) contact with metal objects while activating the wand.No containment or corrective actions are recommended at this time.
Additional Manufacturer Narrative
H11: h2: corrected information h6: medical device problem code.

• Brand Name: PROCISE EZ VIEW 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: 19149834
• Report Number: 3006524618-2024-00156
• Device Sequence Number: 7406886
• Product Code: GEI
• UDI-Device Identifier: 00817470000313
• UDI-Public: 00817470000313
• 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,Followup
• Report Date (Section B): 05/31/2024

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: 07/17/2026
• Device Catalogue Number: EIC8875-01
• Device Lot Number: 2124619
• 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: 03/29/2024
• Supplement Date Received by Manufacturer: 05/20/2024; 05/30/2024
• Initial Report FDA Received Date: 04/20/2024
• Supplement Report FDA Received Date: 05/21/2024; 06/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2023
• 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