MAUDE Adverse Event Report: ARTHROCARE CORPORATION 3.5MM 90 DEGREE ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	AC1340-01
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	08/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a shoulder arthroscopy surgery, tip was used; at the moment of coagulation, solution with this was irrigated, becomes hot and notices burn on the patient skin, this was seen in the same direction in which the solution comes out.Procedure was completed with the same radiofrequency; but parameters of coagulation and cutting were changed.
Additional Manufacturer Narrative
The device was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined since the product was not returned for evaluation.Visual inspection and functional testing could not be performed because the device in question was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.There are several factors that could contribute to the reported event.It was conveyed that the reported burn was in the same direction in which the solution "saline" comes out; therefore, failure to attach the recommended suction properly can result in patient injury.Also, inadequate flow and circulation of saline could cause a patient burn.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.Reviewed during mimb.A medical investigation will be performed.Proceed based on information provided or available for the investigation; if no relevant clinical information is provided, recommend closure.Approved by dr.(b)(6).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.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.) no relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection under magnification shows the cap has been pulled back from the shaft; therefore, causing an opening down into the shaft.There are no manufacturing abnormalities visually observed with the returned device.Due to the damaged cap a functional evaluation could not be conducted; however, further evaluation by engineering found that the fluid seal of the tip was damaged more than likely by forces exerted on the tip.The displaced tip caused damage to the insulation of some of the active electrode conduction wires that pass from the shaft to the tip.The combination of damaged electrode insulation coupled with the presence of saline (a conducting fluid) within the shaft enabled unintended electrical flow between the conduction wires and the shaft.The unintended current flow heated the saline in the shaft, causing higher temperatures in the shaft compared to an intact wand.The complaint has been visually verified and the root cause was more than likely associated with the device potentially coming into contact with a metal object such as a cannula.It is also possible that mechanical displacement of tissue through applied force or using the device as a lever to enlarge a surgical site or gain access to tissue can also cause this type of failure.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: 3.5MM 90 DEGREE ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• MDR Report Key: 7843115
• Report Number: 3006524618-2018-00448
• Device Sequence Number: 11154356
• Product Code: GEI
• UDI-Device Identifier: 00817470001839
• UDI-Public: (01)00817470001839(17)191231(10)1175854
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K033584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2018

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: 12/31/2019
• Device Model Number: AC1340-01
• Device Catalogue Number: AC1340-01
• Device Lot Number: 1175854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Initial Date Received by Manufacturer: 08/23/2018
• Supplement Date Received by Manufacturer: 10/25/2018; 12/17/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 10/26/2018; 12/18/2018
• 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
• Patient Age: 45 YR