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

Model Number	ASH4830-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a knee scope, it was discovered that two separate pieces from the metal tip of the super multivac wand came off the device.The surgeon was able to successfully removed both pieces from the patient's joint space.The procedure was completed with a 30-minute delay using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
H10: h2: additional information on b3, b5 and h6 (health effect - impact code).
Event or Problem Description
It was reported that during a knee scope, it was discovered that two separate pieces from the metal tip of the super multivac wand came off the device.The surgeon was able to successfully removed both pieces from the patient's joint space with arthroscopic graspers.The procedure was completed with a 30-minute delay using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.Visual inspection observed the electrode has been heavily used and thinned.Scratches run across the face of the electrode from contact with hard material.A piece of the electrode is missing.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.When used with a bypass box, coagulation and plasma was generated on the remaining portion 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 no 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 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.

• Brand Name: 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: 16792747
• Report Number: 3006524618-2023-00157
• Device Sequence Number: 12143152
• Product Code: GEI
• UDI-Device Identifier: 00817470004908
• UDI-Public: 00817470004908
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2024

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 Expiration Date: 09/16/2024
• Device Model Number: ASH4830-01
• Device Catalogue Number: ASH4830-01
• Device Lot Number: 2079604
• 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: 03/31/2023
• Supplement Date Received by Manufacturer: 04/25/2023; 02/15/2024
• Initial Report FDA Received Date: 04/22/2023
• Supplement Report FDA Received Date: 04/28/2023; 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2021
• 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