MAUDE Adverse Event Report: ARTHROCARE CORPORATION SUPER TURBOVAC 90 ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number ASC4250-01

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference (b)(4).

Event Description

It was reported that during an unspecified arthroscopy, the electrode on the tip of the super turbovac 90 fell off inside the patient, the electrode was removed from the patient.The procedure was completed with a s+n back up device.It is unknown if there was a surgical delay and no further complications were reported.

Manufacturer Narrative

H10: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection revealed that the returned instrument shows no manufacturing abnormalities.Two of the raised electrodes have eroded from the flat electrode tip of the wand.One of the pieces was returned.Product was out of the original packaging.No packaging returned.A functional evaluation was performed on the returned device and found that the device displayed settings (1,7) when plugged in.Plasma generation and coagulation functioned on the remaining portions of the electrode.The resistance measured at 0.90 kilo ohms.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) hitting the device tip against a hard surface.(2) using the device as a lever to enlarge surgical site.(3) activating the device above recommended settings for prolonged periods of time.No containment or corrective actions are recommended at this time.H11: corrected information in h6 (health effect - impact code).

• Brand Name: SUPER TURBOVAC 90 ICW
• Type of Device: 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: 18897605
• MDR Text Key: 337594860
• Report Number: 3006524618-2024-00095
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470006421
• UDI-Public: 00817470006421
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASC4250-01
• Device Lot Number: 2134444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1