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

Model Number	ASC4630-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during an arthroscopic repair of the hip glenoid lip, outside the patient, the electrode of the tristar wand fell off.The procedure was completed without delay using a back-up device.No patient 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 concluded this was a repeat issue.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.¿.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection of the returned instrument shows no manufacturing abnormalities.The electrode is completely detached.The wand cable has been cut and removed.Product was out of the original packaging.No packaging returned.A functional evaluation could not be conducted due to the wand cable being cut and removed from wand.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.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.It was determined the device contributed to 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.

• 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: 13448357
• Report Number: 3006524618-2022-00044
• Device Sequence Number: 5437116
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2022

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: 02/28/2023
• Device Model Number: ASC4630-01
• Device Catalogue Number: ASC4630-01
• Device Lot Number: 2051575
• 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: 01/17/2022
• Supplement Date Received by Manufacturer: 03/10/2022; 05/25/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 03/11/2022; 05/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2020
• 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
• Patient Sex: Female