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

Catalog Number	ASHA4830-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that after surgery, on (b)(6)2023, the tip of the ambient super multivac wand was discovered inside the patient, on a post-operative radiography.During an arthroscopy, the tip of the electrode fell off.The output time of the wand was about 2 minutes.The procedure was completed with a 10-minute surgical delay.A revision surgery was performed on (b)(6)2023, to retrieve the tip of the electrode from the patient's body.No further complications were reported.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.Visual inspection observed the returned instrument shows no manufacturing abnormalities.The electrode top has been eroded from the spacer tip.The electrode legs are still embedded in the spacer tip.Bio debris is present.Product was out of the original packaging.No packaging returned.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, coagulation and plasma were generated on the remaining portions of the electrode.The resistance measured at 1.05 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.The root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include (1) hitting the tip against a hard surface such as a metal or bone, (2) mechanical displacement of the tip through applied force or an impact event, (3) using the wand above default output settings causing excessive electrode erosion.No containment or corrective actions are recommended at this time.

• 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: 17483461
• Report Number: 3006524618-2023-00312
• Device Sequence Number: 8942277
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2024

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: 09/14/2025
• Device Catalogue Number: ASHA4830-01
• Device Lot Number: 2101095
• 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: 07/18/2023
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2022
• 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: Other; Required Intervention
• Patient Sex: Unknown