MAUDE Adverse Event Report: ARTHROCARE CORP. COVATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number AC4340-01

Device Problem Flaked (1246)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during a capsular release surgery, a small metal piece peel off from the tip of the 'covator 20' wand.The procedure was completed with a non-significant delay using a backup device.All the pieces were removed from the patient using outflow suction.The patient was normal and discharged.No further complications were reported.

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 no 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 per complaint details, the small metal tip of the device ¿peel off¿ during a capsular release surgery; however, all pieces were removed from the patient using outflow suction.Reportedly the procedure was completed with a non-significant delay using a backup device with no injury reported.It was communicated that the patient was ¿normal and discharged¿.Based on the limited information provide, the root cause of the reported event cannot be definitively concluded.Patient impact beyond the reported 0-30 minute surgical delay, foreign body removal via suction and use of a backup device to complete the procedure would not be anticipated as no further complications were reported and patient was ¿normal and discharged¿.No further medical assessment can be rendered at this time.A review of the customer provided images shows the original packaging and a piece 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.

• Brand Name: COVATOR
• Type of Device: 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: 13847374
• MDR Text Key: 287610503
• Report Number: 3006524618-2022-00097
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470003314
• UDI-Public: 00817470003314
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K033584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2023
• Device Model Number: AC4340-01
• Device Catalogue Number: AC4340-01
• Device Lot Number: 2063902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2022
• Date Device Manufactured: 11/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention