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	06/15/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while the wand was passing through a skin portal during a knee arthroscopy the tip broke off the sabre 30 wand.No patient injury was reported.Back-up device was available.
Additional Manufacturer Narrative
There was a relationship found between the device and the reported incident.Visual inspection under magnification of the device shows extensive electrode wear.The electrode is broken off.The cable of the device is cut and was returned with the device.The broken off electrode part is discolored.There are no manufacturing abnormalities visually observed with the returned wand.Due to the cut cable/connector a functional test is impossible.No manufacturing abnormalities were found and not root cause could not be verified.The complaint was verified and the root cause could not be determined but possibly due to extensive use which may result from vigorous use against bony surfaces.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: 7616646
• Report Number: 3006524618-2018-00330
• Device Sequence Number: 16473207
• Product Code: GEI
• UDI-Device Identifier: 00817470004854
• UDI-Public: (01)00817470004854(17)210109(10)2009536
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2018

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: 01/09/2018
• Device Model Number: AC4330-01
• Device Catalogue Number: AC4330-01
• Device Lot Number: 2009536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Initial Date Received by Manufacturer: 06/16/2018
• Supplement Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 08/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1