MAUDE Adverse Event Report: ARTHROCARE CORPORATION TOPAZ XL ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	AC4045-01
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Event or Problem Description
It was reported that during set up of a procedure, the topaz wand could not be inserted to the black slot.It was not able to ablate nor coagulate.Back up device was available.A non-significant delay was reported.No further complications were reported.As per the preliminary results of the investigation, the visual inspection showed the electrode is detached.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: upon review during closure stage, it was determined that this event was already reported under (b)(6) in report 3006524618-2024-00114.Thus it will updated to non-reportable.H11: corrected information in h10.

• Brand Name: TOPAZ XL ICW
• 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: 18771302
• Report Number: 3006524618-2024-00081
• Device Sequence Number: 11906945
• Product Code: GEI
• UDI-Device Identifier: 00817470003116
• UDI-Public: 00817470003116
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K080282
• 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): 07/15/2024

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: 11/25/2023
• Device Catalogue Number: AC4045-01
• Device Lot Number: 2065300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2020
• 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