MAUDE Adverse Event Report: ARTHROCARE CORP. PROCISE XP COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number EICA8872-01

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 09/04/2020

Event Type  Injury  

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records for the device showed there were 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 review of the instructions for use found statements related to electrode erosion and detachment.A review of risk management files found that the reported failure was documented appropriately.Visual inspection of the device showed detachment of one of the electrodes.The device was connected to a known good controller, which revealed that the wand's mechanical use limiting system was not activated.The remaining "life" was extinguished and a bypass box was used, which revealed that the device's ablate and coagulate functions performed as intended.Suction and saline lines performed as intended.The complaints were verified as the device experience a detached electrode.Factors, which may have contributed to the reported complaint include: hitting the device tip against a hard surface such as an insertion cannula.Using the device as a lever to enlarge surgical site.Mechanical displacement of tissue through applied force.Activating the device above recommended settings for prolonged periods of time.No containment or corrective actions are recommended at this time.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

Event Description

It was reported that, during a tonsillectomy procedure, the electrodes of the "procise xp wand" burnt out fast.The procedure was successfully completed without delay using a back-up device.No patient injuries or other complications were reported.Results of investigation have concluded that visual inspection of the device showed detachment of one of the electrodes and this is a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: PROCISE XP COBLATOR II
• 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: 10738561
• MDR Text Key: 213211768
• Report Number: 3006524618-2020-00924
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470003727
• UDI-Public: 00817470003727
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2022
• Device Model Number: EICA8872-01
• Device Catalogue Number: EICA8872-01
• Device Lot Number: 2045239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Date Manufacturer Received: 10/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2019
• 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