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

Model Number AMBIENT SUPER TURBOVAC 90 IFS

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 05/26/2020

Event Type  malfunction  

Event Description

It was reported that, during an arthroscopic surgery, the "ambient supertvac 90° ifs wand" showed an error e4 when it was connected to the quantum control unit.The procedure was successfully completed without delay using a back-up device.No patient injuries or other complications were reported.

Manufacturer Narrative

H3, h6: the device, used in treatment, was returned for evaluation.There was a 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; this failure mode will be trended to assess for any necessary corrective actions.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.There were no manufacturing abnormalities found on the device.Functional evaluation revealed an e7 error, after bypassing the error e-7 the wand did not generate plasma, after a couple of seconds during activation the controller showed error e4 ¿wand short¿ with the red attention led and alarm sound activated.The failure could not be reset.Testing the suction line showed that it is partially clogged at distal end.Dissecting the wand revealed no manufacturing abnormalities.Continuity testing revealed that the wand is shorted at distal end.The complaint was verified as the device displayed an e4 error, the root cause was determined to be due component failure.Factors, which may have contributed to the reported complaint include: striking the tip of the wand on a conductive surface which may cause a wand short and lead to an e-4 error.A minute trace of saline breaking the barrier of the cap and shaft will cause the controller to generate an e-4 error as it will occur if the generator detects a power spike.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: 10151485
• MDR Text Key: 195248174
• Report Number: 3006524618-2020-00377
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470000016
• UDI-Public: 00817470000016
• Combination Product (y/n): N
• PMA/PMN Number: K033584
• 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: 07/24/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2022
• Device Model Number: AMBIENT SUPER TURBOVAC 90 IFS
• Device Catalogue Number: ASHA4250-01
• Device Lot Number: 2042123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Distributor Facility Aware Date: 05/28/2020
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/14/2020
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1