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

Model Number ASHA4250-01

Device Problems Defective Component (2292); Device Displays Incorrect Message (2591)

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

Event Date 03/11/2020

Event Type  malfunction  

Manufacturer Narrative

The device, intended for use in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined since the product was not returned for evaluation.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.Visual inspection and functional testing could not be performed since the device was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.Factors, which may have contributed to the complaint event include: 1)the rf controller may have been turned off following connection of the wand or source power may have been interrupted.2) the wand incorporates a single-use feature which is designed to prevent reuse of the wand.3) disconnecting the wand from the controller after power has been turned on 4) previous use or incorrect power cycling of the controller.5) a reprocessed wand will an exhibit error.There are no indications to suggest the device did not meet product specifications upon release into distribution.

Event Description

It was reported that during knee arthroscopy meniscal suture surgery, the doctor requested the ambient radio frequency super turbovac 90 ifs and it was normally opened and located at the instrumentation's table.At the time of connection, the console made a sound and sent an error message, the doctor tried to use the shaver but it did not work.No significant delay and a back up was used to complete the procedure.No patient injury was reported.

Manufacturer Narrative

'date received by manufacturer' was updated.

Manufacturer Narrative

H10: 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 a related failure; this failure mode will be trended to assess for any necessary corrective actions.Visual inspection of the device revealed minimal erosion of electrodes/screen and contamination around the tip.The device's resistance was measure to be 1.0 kohms.The device was connected to a known good controller which displayed an "e7 error".The device was then connected to the known good controller using a bypass box, which revealed the device performed as intended.The complaint was verified as the device showed an e7 error.The root cause could not be determined.Factors, which may have contributed to the reported complaint include: (1) previous use (2) disconnecting the wand from the controller after power has been turned on.(3) an issue with one of the concomitant devices in use at the time of this complaint event.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: 10031298
• MDR Text Key: 190602504
• Report Number: 3006524618-2020-00239
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2020

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: 09/26/2022
• Device Model Number: ASHA4250-01
• Device Catalogue Number: ASHA4250-01
• Device Lot Number: 2041353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 05/06/2020
• Supplement Dates Manufacturer Received: 04/29/2020; 07/24/2020
• Supplement Dates FDA Received: 05/08/2020; 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention