MAUDE Adverse Event Report: ARTHROCARE CORP. AMBIENT HIPVAC 50 IFS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	72290004
Medical Device Problem Codes	Image Display Error/Artifact (1304); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a hip surgery an e6 error code occurred, site had to open another one to use.The procedure was successfully completed without delay.No patient injury or other complications were reported.Results of investigation have concluded that the insulation shaft was damaged, which makes it a reportable event.
Additional Manufacturer Narrative
The correct date we became aware of this reportable event is 2/4/2020.
Additional Manufacturer Narrative
H10.H3, h6: the ambient hipvac 50 ifs wand, used in treatment, was returned for evaluation.A relationship between the device and reported incident was established.A device history review/batch record review for lot finding no discrepancies from released and operating procedures nor conditions that could contribute to the event.The review of the complaint history for the associated complaint product found no similar events in the last three years for the involved lot.Visual inspection shows no wear of the electrodes.There are scratches and scuff marks on the insulation shaft, and two significant openings.Cut wires can be seen in the back of the insulation shaft, where the thermocouple wires connect.No manufacturing discrepancies observed.During functional evaluation the fuse resistance was measured and registered 1,213 ohms prior to activation and this indicated a blown fuse.The wand was connected to a compatible quantum 2 controller and registered an e7-error that was by-passed using a fixture box.An open t/c (thermocouple) occurred.The device was dismantled and no loose connection was observed inside the handle.Continuity was tested on the positive and negative thermocouple pins (11 and 12) inside the connector block to the green/red wires at the tip of the wand.No reading was registered indicating no resistance inside the wand circuit.No containment or corrective actions are recommended at this time.The complaint was verified and the root cause can not be determined with confidence.Factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: it is most likely that the mechanical damage on the back area of the shaft, near the tip of the wand where the thermocouple wires connect, is preventing the temperature reading and causing the e6 error.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: AMBIENT HIPVAC 50 IFS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 9742700
• Report Number: 3006524618-2020-00050
• Device Sequence Number: 1973987
• Product Code: GEI
• UDI-Device Identifier: 00885556614686
• UDI-Public: 00885556614686
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161481
• 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,Followup
• Report Date (Section B): 02/27/2020

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: 05/11/2022
• Device Model Number: 72290004
• Device Catalogue Number: 72290004
• Device Lot Number: 2032708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 02/04/2020; 02/20/2020
• Initial Report FDA Received Date: 02/22/2020
• Supplement Report FDA Received Date: 02/24/2020; 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1