MAUDE Adverse Event Report: ARTHROCARE CORPORATION AMBIENT SUPER MULTIVAC 50 IFS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	ASHA4830-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an acl, an ambient super multivac´s tip electrode fell off.The broken pieces were removed from the patient.Surgery resumed after a non-significant delay, however it is unknown, how the procedure was finished.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.Visual inspection observed the electrode is missing.The electrode posts are still in the tip.Bio debris is present.Product was out of the original packaging.No packaging returned.A functional evaluation revealed the controller generated an e7 error when the wand was connected.The resistance measured at 1.30 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.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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.A clinical review states based on the limited information provided, a thorough clinical assessment cannot be performed at this time and the patient impact beyond the reported events could not be determined.The root cause has been associated with unintended use of the device.Factors that could have contributed to the reported event include: (1) hitting the device tip against a hard surface.(2) using the device as a lever to enlarge surgical site.(3) mechanical displacement of tissue through applied force.(4) 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: AMBIENT SUPER MULTIVAC 50 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: 16148018
• Report Number: 3006524618-2023-00039
• Device Sequence Number: 6867472
• Product Code: GEI
• UDI-Device Identifier: 00817470006551
• UDI-Public: 00817470006551
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180848
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2025
• Device Model Number: ASHA4830-01
• Device Catalogue Number: ASHA4830-01
• Device Lot Number: 2095444
• 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: 12/23/2022
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown