MAUDE Adverse Event Report: ARTHROCARE CORP. ELIMINATOR ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	AC1345-01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the wand presented a cutting/coagulation failure without giving any warning signal.No significant delay or patient injuries were reported.The procedure was completed with the electrobisturi of the institution.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 not returned for evaluation.A relationship between the reported event and the device could not be established.A review of the device history records for the reported lot number 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 for lot number for the past 3 years found related failures; this failure mode will be trended by post market surveillance to assess for any necessary corrective actions.No containment or corrective actions are recommended at this time.Without the reported product a visual inspection and functional evaluation cannot be performed and customer´s complaint cannot be confirmed.Potential factors unrelated to the design or manufacture of the device that may lead to ¨ablate / coag issue / wand does not activate¨ include, but are not limited to: not having sufficient saline in order to facilitate the formation of plasma there are no indications to suggest that the device/product did not meet specifications upon release into distribution.

• Brand Name: ELIMINATOR ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 9562057
• Report Number: 3006524618-2020-00010
• Device Sequence Number: 14034905
• Product Code: GEI
• UDI-Device Identifier: 00817470001860
• UDI-Public: 00817470001860
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2022
• Device Model Number: AC1345-01
• Device Catalogue Number: AC1345-01
• Device Lot Number: 2027093
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 47