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

Model Number EIC8872-01

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 10/19/2020

Event Type  Injury  

Event Description

It was reported that during a tonsillectomy surgery, the metal electrode wire of the procise wand was fracture.Unknown if there was a delay.Smith and nephew back-up device was available to complete the surgery.No other complications reported.It was also noticed that the wand was used beyond its expiration date.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: h2, h6.The device, used in treatment, was not returned for evaluation.There was a relationship found between the device and the reported incident, as an image of the device was submitted by the customer.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 risk management files found that the reported failure was documented appropriately.A review of the instructions for use found that excessive applied force can result in device damage.A visual investigation of the customer submitted images show a device which electrode appears damaged.Clinical evaluation was completed and concluded that based on the limited information provided the root cause of the reported wand electrode breakage could not be determined.The device ifu does caution that ¿prior to initial use, ensure that all package inserts including warnings, cautions, user¿s manual and instructions for use are read and understood.¿ although the cytotoxicity report notes that the device passed cytotoxicity testing and is considered non-toxic, this is for short term use.Long term implantation data is not available.If retained the patient impact beyond possible micro-motion and/or migration, local irritation/discomfort, and probable mri restrictions cannot be determined.No further medical assessment can be rendered at this time.Visual inspection and functional testing could not be performed since the device was not returned for evaluation; however, the complaint was confirmed as the submitted image provide sufficient evidence to confirm.Potential factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: (1) rate of ablation (2) fluid management (3) extensive use.There are no indications to suggest the device did not meet product specifications upon release into distribution.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• 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
• MDR Report Key: 10812202
• MDR Text Key: 215372174
• Report Number: 3006524618-2020-00970
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470000368
• UDI-Public: 00817470000368
• Combination Product (y/n): N
• PMA/PMN Number: K070374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2020
• Device Model Number: EIC8872-01
• Device Catalogue Number: EIC8872-01
• Device Lot Number: 2006308
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention