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

Catalog Number	ASHA4250-01
Medical Device Problem Codes	Circuit Failure (1089); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).The following are the lot numbers reported: 2 devices from lot: 2151656 and a third unknown lot number.However, it is unknown which of the 3 devices contributed with the delay greater than 30 minutes.D4, exp.Date: expiration date is: 16-apr-2027 (2151656).H4, mgf.Date: manufacturing date is: 16-apr-2024 (2151656).
Event or Problem Description
It was reported that, during a shoulder procedure, three ambient super turbovac 90 wands failed.The first wand was connected to the controller and did not work.The other two were connected and worked initially, but quickly stopped working.Surgery was completed with a back-up device instead.There was a surgical delay greater than 30 minutes and no further complications were reported.
Additional Manufacturer Narrative
H6, medical device problem code was corrected.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation along with two other devices.A visual inspection revealed no manufacturing abnormalities.The electrode on all three devices have been used, bio debris is present, and the devices were returned out of the original packaging (no packaging returned).A functional evaluation was performed on the returned devices and found all produced an e7 error when the wand was connected after the controller was powered on.A bypass box was used to test the devices, and for device one, coagulation and plasma were generated as intended (the resistance was measured at 1.40 kilo ohms).The device two generated an e6 error (the resistance was measured at 1.61 kilo ohms).For device three, coagulation and plasma were generated as intended (the resistance was measured at 1.40 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 failure include a short in the wand or a damaged t/c wire between the transition of the handle and the shaft.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: 19913929
• Report Number: 3006524618-2024-00303
• Device Sequence Number: 7361193
• Product Code: GEI
• UDI-Device Identifier: 00817470000016
• UDI-Public: 00817470000016
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2024

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 09/06/2024; 09/11/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 09/11/2024; 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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