MAUDE Adverse Event Report: ARTHROCARE CORPORATION WEREWOLF RF 20000 CONTROLLER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	72290105
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that on clinical review pmcf for turbovac 90 xl icw, multivac 50 xl icw & topaz ez ifs, during a procedure to treat a hip fracture of 1 patient, while using a topaz wand and a werewolf controller that took too long to turn on in order to perform the coagulation and the patient suffered a bleeding that was difficult to control.After this the patient required a revision surgery due to a rebleeding and required hemostasis.Additionally an atlas foot pedal and a lens integrated system were used.Patient outcome is unknown.No further information is available.
Additional Manufacturer Narrative
H10, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, 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 this clinical study information was provided in an excel spreadsheet following retrospective post-market clinical follow up where the data is anonymized.According to the complaint, additional information is not available.Consequently, without patient-specific clinically relevant supporting documentation the reported difficult to control bleeding following the use of the topaz wand and werewolf controller cannot be confirmed.Or could a definitive clinical root cause of the reported issue be determined.Per the complaint, the patient required a revision surgery due to a rebleeding and required hemostasis, in addition to, an atlas foot pedal and a lens integrated system were used.Since it was reported the patient¿s outcome is unknown, the impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Should any additional relevant medical information be provided, this case would be re-assessed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.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.

• Brand Name: WEREWOLF RF 20000 CONTROLLER
• 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: 16797090
• Report Number: 3006524618-2023-00162
• Device Sequence Number: 19618016
• Product Code: GEI
• UDI-Device Identifier: 00885556624890
• UDI-Public: 00885556624890
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2023

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 Model Number: 72290105
• Device Catalogue Number: 72290105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 07/24/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR
• Patient Sex: Male