MAUDE Adverse Event Report: ARTHROCARE CORP. EVAC 70 XTRA HP COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EICA5874-01
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the wand was not sucking naci back into the tip of the wand.Patient experienced post operative bleeding.
Additional Manufacturer Narrative
There was no relationship found between the returned device and the reported incident.Visual inspection under magnification shows minimal electrode wear with dried blood/tissue present on and under the electrodes.There are no manufacturing abnormalities visually observed with the returned wand.The wand was connected to a compatible coblator ii controller and activated in a beaker of saline solution at the default and max settings and performed as intended.The saline line was connected to a saline bag at approximately 3 feet and saline flowed through-out the line to the tip of the device as intended.The suction line was tested and saline flowed through-out the line without hesitation.The complaint could not be verified and the root cause could not be determined with confidence.Factors that could have led to post-operative bleeding includes: health and patient's compliance to post-op instructions, types of food consumed, certain medicines and/or bleeding disorders that are known to reduce the body's ability to clot.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Reviewed during mimb.A medical investigation will be performed.Wait on all information requests.Proceed based on information provided/available for the investigation; if no further clinical information is provided, recommend closure.Approved by dr.Luca orlandini and/or j.Templeton, medical director.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: ·patient information ·surgical procedure/post-operative care review ·device labeling (including technique guides, ifus, etc.) post-tonsillectomy bleeding is a known common occurrence of the procedure.There is no patient data provided, and the device will not be returned for evaluation.The information provided is insufficient to determine the exact cause of the bleeding.Therefore, the exact root cause of the repeated bleeding cannot be determined at this time, and the patient's current condition is unknown.No further clinical assessment is warranted based on the information available.Post-tonsillectomy bleeding is a known common occurrence of the procedure.There is no patient data provided, and the device will not be returned for evaluation.The information provided is insufficient to determine the exact cause of the bleeding.Therefore, the exact root cause of the repeated bleeding cannot be determined at this time, and the patient's current condition is unknown.No further clinical assessment is warranted based on the information available.

• Brand Name: EVAC 70 XTRA HP COBLATOR II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon drive; austin TX 78735
• MDR Report Key: 7775823
• Report Number: 3006524618-2018-00412
• Device Sequence Number: 16570357
• Product Code: GEI
• UDI-Device Identifier: 00817470004007
• UDI-Public: (01)00817470004007(17)210220(10)2010900
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K070374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/20/2021
• Device Model Number: EICA5874-01
• Device Catalogue Number: EICA5874-01
• Device Lot Number: 2010900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 08/12/2018
• Supplement Report FDA Received Date: 09/07/2018
• 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: Other