MAUDE Adverse Event Report: ARTHROCARE CORP. AMBIENT SUPER TURBOVAC 90 IFS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number ASHA4250-01

Device Problems Device Alarm System (1012); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

Foreign zip code: (b)(6).

Event Description

It was reported that during the surgery the wand was plugged into the quantum 2, an error e7 appeared on the panel and there was a loud noise generated by the console.No patient injuries reported.No significant delay reported.Surgery was finished using a competitive device.

Event Description

It was reported that during the surgery the wand was plugged into quantum 2, an error e7 appeared on the panel and there was a loud noise generated by the console.No patient injuries reported.No significant delay reported.Surgery was finished using a competitor device.

Manufacturer Narrative

The returned device, intended for use in treatment, was returned for evaluation.There was a relationship between the returned device and the reported event.Visual inspection under magnification of the wand shows moderate electrode wear.The insulation on the shaft is in its original condition.There are no manufacturing abnormalities visually observed with the returned wand.The wand was connected to a compatible quantum controller and registered an e-7 error.After by-passing the error, the wand performed as intended.The suction line was tested and performed as intended.The complaint was verified with several root causes that could have contributed the reported error.The rf controllers may have been turned off following connection of the wand or source power may have been interrupted prior to wand activation.Other factors that could contribute to this kind of errors include disconnecting the wand from the controller after power has been turned on; previous use or incorrect power cycling of the controller.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: AMBIENT SUPER TURBOVAC 90 IFS
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 9108960
• MDR Text Key: 165563228
• Report Number: 3006524618-2019-00482
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470000016
• UDI-Public: 00817470000016
• Combination Product (y/n): N
• PMA/PMN Number: K083306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2022
• Device Catalogue Number: ASHA4250-01
• Device Lot Number: 2025512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Date Manufacturer Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1