MAUDE Adverse Event Report: ARTHROCARE CORP. CATALOG WIRELESS FOOT CONTROL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	72290007
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during an unknown surgery, when the wireless foot control was pressed to used the starvac wand, the wand did not stop burning when the foot control was released.The wand was not touching the patient's tissue.It was quickly disconnected and replaced by hand controlled wand (super turbo vac).The procedure was completed without significant delay.No patient injury or other complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A relationship, if any, between the subject device and the reported event could not be determined.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.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.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.Visual inspection observed no issues.Functional evaluation revealed the foot pedal does not function or activate with the returned wireless receiver.Using another foot pedal with the receiver also did not result in activation.The complaint was confirmed and the root cause is associated with a component failure.Factors, which could have contributed to the complaint event, include, failure of an internal component which could cause the device to not activate or send a wireless signal.No containment or corrective actions are recommended at this time.
Additional Manufacturer Narrative
D4: serial number.

• Brand Name: CATALOG WIRELESS FOOT CONTROL
• 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: 12472025
• Report Number: 3006524618-2021-00909
• Device Sequence Number: 11735215
• Product Code: GEI
• UDI-Device Identifier: 00885556618417
• UDI-Public: 00885556618417
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K011634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/08/2023

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 Model Number: 72290007
• Device Catalogue Number: 18802-08
• Device Lot Number: L143520003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 10/08/2021; 02/06/2023; 02/06/2023
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 10/11/2021; 02/08/2023; 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown