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

Catalog Number	ASHA4250-01
Medical Device Problem Codes	Failure to Deliver Energy (1211); Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during an arthroscopic procedure, the turbovac wand's ablate function was activated even though no hand button or foot pedal was pressed.Surgery was completed with a back-up device instead.There was a 5 minute surgical delay, and no further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H10 h3, h6: the reported device was received for evaluation.A visual inspection observed the returned instrument shows no manufacturing abnormalities.The electrode has been used.Bio debris is present.Product was out of the original packaging.No packaging returned.The unit was inspected internally and found saline ingress on all three button components, which has caused the metal to degrade and short.A functional evaluation revealed an e7 error was generated when the wand was connected after the controller was powered on.When used with a bypass box, the device displayed setting of (0,0).When the wand was activated, it stayed activated without the hand or foot function.Coagulation and plasma could not be produced.The resistance measured at 1.61 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 a component failure.Factors that could have contributed to the failures include contact to a conductive material such as another metal device, saline ingress, a wand short, incomplete connection, or the wand´s connector or cable got damaged.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: AMBIENT SUPER TURBOVAC 90 IFS
• 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: 20055114
• Report Number: 3006524618-2024-00333
• Device Sequence Number: 12751590
• Product Code: GEI
• UDI-Device Identifier: 00817470000016
• UDI-Public: 817470000016
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083306
• 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): 09/30/2024

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 Catalogue Number: ASHA4250-01
• Device Lot Number: 2142362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2024
• 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