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

Model Number	EICA6895-01
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the turbinator coblator ii was not ablating; the procedure was successfully completed without delay using a reflux ultra ptr device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10 h3,h6: 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 no ablation.A review of risk management files found that the reported failure was documented appropriately.Visual inspection of the device showed moderate erosion of the screen and some discoloration of the spacer.The device was connected to a known good controller, which revealed that the wand's mechanical use limiting system was activated, preventing the output of the wand.The wand was then bypassed, which revealed that the device's ablate and coagulate functions performed as intended.Suction and saline lines performed as intended.The complaint was verified as the device was unable to operate outside of the use of a bypass box.The root cause was determined to be due to reuse of a single use device.Factors, which may have contributed to the reported complaint include: previous use, disconnecting the wand from the controller after power has been turned on.(3) an issue with one of the concomitant devices in use at the time of this complaint event.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: TURBINATOR COBLATOR II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10568886
• Report Number: 3006524618-2020-00802
• Device Sequence Number: 2705344
• Product Code: GEI
• UDI-Device Identifier: 00817470005240
• UDI-Public: 00817470005240
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2020

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 Expiration Date: 07/13/2022
• Device Model Number: EICA6895-01
• Device Catalogue Number: EICA6895-01
• Device Lot Number: 2036966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 10 YR
• Patient Weight: 51