MAUDE Adverse Event Report: ARTHROCARE CORP. STARVAC 90 ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	ASC4251-01
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arcr procedure, device was not getting an energy output, device did not present any error code or audible alarm.Procedure was successfully completed with a competitor device.No delay or patient injuries reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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.A review of manufacturing records found no deviations or non-conformance's during the manufacturing process.A complaint history review found no related failures; this failure mode will be trended to assess for any necessary corrective actions.Visual inspection under magnification of the wand shows minimal electrode and screen wear with contamination/discoloration and scratch/scuff marks on the spacer and cap.The device met all specification upon release into distribution.The complaint was not verified as the device performed as specified after a back flush of the suction line.When the suction line was not properly connected or (2) the suction pressure at the customer¿s facility may have not supplied enough pressure in order to excavate tissue.When the recommended suction pressure is not used, this will cause the suction line to clog; therefore, decreasing the functionality of the wand.There are no indications to suggest the device did not meet product specifications upon release into distribution.

• Brand Name: STARVAC 90 ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 9664157
• Report Number: 3006524618-2020-00040
• Device Sequence Number: 16269013
• Product Code: GEI
• UDI-Device Identifier: 00817470001716
• UDI-Public: 00817470001716
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2020

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: 04/23/2022
• Device Model Number: ASC4251-01
• Device Catalogue Number: ASC4251-01
• Device Lot Number: 2031771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 05/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1