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

Model Number	EICA7070-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cyst(s) (1800)
Date of Event	07/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).Literature: minimally invasive procedure for diagnosis and treatment of vallecular cysts in children: review of 156 cases.Doi: 10.1007/s00405-020-06163-9.
Event or Problem Description
It was reported that on literature review ¿*minimally invasive procedure for diagnosis and treatment of vallecular cysts in children: review of 156 cases.¿, after surgery with a "procise lw coblator ii wand" a patient had a recurrent cyst.The complication was treated with an additional surgery.No further information is available.
Additional Manufacturer Narrative
H3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was a repeat issue.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.A clinical review states the data provided was presented in the literature article named " minimally invasive procedure for diagnosis and treatment of vallecular cysts in children: review of 156 cases." without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: PROCISE LW COBLATOR II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 12109101
• Report Number: 3006524618-2021-00741
• Device Sequence Number: 17156752
• Product Code: GEI
• UDI-Device Identifier: 00817470004243
• UDI-Public: 00817470004243
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K202006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021

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 Model Number: EICA7070-01
• Device Catalogue Number: EICA7070-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 10/15/2021
• 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: 2 YR