MAUDE Adverse Event Report: ARTHROCARE CORP. SABER 30 DEGREE ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	AC4330-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after deactivation of the wand the machines error alarm went off.I unplugged the wand and the alarm still went off.I the switched the quantum 2 off to silence the machine.A competitor wand was used to complete the procedure.No patient injuries were reported.
Additional Manufacturer Narrative
The device, intended for use in treatment, was not returned for evaluation.We cannot determine if there is a relationship between the device and the incident because 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 and a root cause could not be determined with confidence factors that could have led to an error message ¿alarm¿ includes: it is possible that an e-1 error was experienced which is due to both the ablate and coagulation buttons being simultaneously activated.Also, an e-2 may have been experienced which can be caused by the wand becoming disconnected when the foot control was inadvertently activated.Other factors unrelated to the manufacture or design of the device which could have contributed to the reported event is the controller or foot control which were not returned for evaluation.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: SABER 30 DEGREE ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7107362
• Report Number: 3006524618-2017-00410
• Device Sequence Number: 1182665
• Product Code: GEI
• UDI-Device Identifier: 00817470004854
• UDI-Public: (01)00817470004854(17)180201(10)1096515
• Combination Product (Y/N): N
• PMA/510(K) Number: K033584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2018

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: 02/01/2018
• Device Model Number: AC4330-01
• Device Catalogue Number: AC4330-01
• Device Lot Number: 1096515
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 02/02/2018
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1