MAUDE Adverse Event Report: ARTHROCARE CORP. TRISTAR 50 ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	ASC4630-01
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, the metal electrode of a tristar wand fell off.Surgery was resumed without any delay, with a back-up device.Patient´s current health status is good.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.The instructions for use was 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 this case reports that the electrode of the tristar wand fell off and it is unknown if the electrode was retrieved from the patient.Based on the limited information provided the root cause of the reported events could not be determined.The wand is an externally communicating device, it is neither manufactured nor intended for implantation.It is also not approved for long term internal tissue exposure and long-term implantation data is not available.The patient impact beyond the reported device breakage and possible retained foreign body could not be definitively determined.If retained micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.No further clinical/medical assessment is warranted at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of the customer provided image shows there is metal ball detached from the electrode.There was a relationship found between the device and the reported event.The complaint was confirmed and the root cause was 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.No containment or corrective actions are recommended at this time.H6: health effect - impact code.
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 is missing a ball in one corner, the rest of the electrode is present.Product was out of the original packaging.No packaging returned.The device was plugged into the controller and registered settings (1,7).The wand had no issues generating plasma with the remaining electrode.A review of the customer provided image shows there is metal ball detached from the electrode.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.The instructions for use was 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 the wand is an externally communicating device, it is neither manufactured nor intended for implantation.It is also not approved for long term internal tissue exposure and long-term implantation data is not available.The patient impact beyond the reported device breakage and possible retained foreign body could not be definitively determined.If retained micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.The root cause was 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.No containment or corrective actions are recommended at this time.

• Brand Name: TRISTAR 50 ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15188375
• Report Number: 3006524618-2022-00343
• Device Sequence Number: 5808280
• Product Code: GEI
• UDI-Device Identifier: 00817470001921
• UDI-Public: 00817470001921
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K033584
• Number of Events Summarized: 1
• Summary Report (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): 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: 05/13/2023
• Device Model Number: ASC4630-01
• Device Catalogue Number: ASC4630-01
• Device Lot Number: 2055215
• 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: 07/18/2022
• Supplement Date Received by Manufacturer: 01/04/2023; 12/22/2023
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 01/05/2023; 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2020
• 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