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

Model Number ASHA4250-01

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 05/24/2020

Event Type  malfunction  

Event Description

It was reported that during shoulder scope procedure, the ambient super turbovac showed an e6 error code upon connected to quantum before we proceed with the surgery.A backup device was available to complete the procedure with no significant delay or patient injuries.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3, h6: the device, used in treatment, was returned for evaluation.There was no relationship found between the returned device and the reported incident.A review of manufacturing records for the reported lot number found no non-conformances or anomalies during manufacturing process related to the reported event.A complaint history review found no related failures.Visual inspection under magnification of the wand shows minimal electrode and screen erosion with contamination/discoloration and scratch/scuff marks on the spacer and cap.Prior to activation the wands resistance was measured with 1502 ohms.After bypassing the error e-7 the device produced plasma on ablate/coag min./max.Settings as intended; the suction line was tested and performed as intended.The complaint was not confirmed and the root cause could not be determined as the device did not display an e6 error.Factor(s), which may have contributed to the reported complaint include: 1- not having sufficient suction pressure in order to ensure adequate flow and circulation of saline solution to prevent unnecessary heating which could have caused the temperature to elevate and trigger the controller alarm 2- it is possible the shaft was harmed by hitting a hard or bony structure; this would have caused the solder at the thermocouple wire to become separated and result in an open tc circuit.3- an issue with a concomitant device (controller, accessory) used in conjunction with the complaint device.There were no indications 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: 10151449
• MDR Text Key: 195163940
• Report Number: 3006524618-2020-00373
• 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: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2022
• Device Model Number: ASHA4250-01
• Device Catalogue Number: ASHA4250-01
• Device Lot Number: 2045145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Distributor Facility Aware Date: 05/24/2020
• Date Manufacturer Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1