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

Model Number ASHA4830-01

Device Problem Protective Measures Problem (3015)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2020

Event Type  Injury  

Event Description

It was reported that during a procedure when the wand was inserted there was an error message on the screen and an alarm sounded.The procedure was completed with a competitor device and no significant delay.No further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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.A complaint history review found related failures; this failure mode will be trended to assess for any necessary corrective actions.A review of the instructions for use found precautionary about single use.A review of risk management files found that the reported failure was documented appropriately.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.Factors that could have contributed to the reported event include: the rf controller may have been turned off following connection of the wand or source power may have been interrupted.The ambient super multivac 50 ifs wand incorporates a single-use feature which is designed to prevent reuse of the wand.There are other factors that could contribute to an e-3 error such as disconnecting the wand from the controller after power has been turned on, previous use or incorrect power cycling of the controller.Also, a reprocessed wand used by the customer will exhibit an e-3 error.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.Correction in h6: health effect - clinical code.

• Brand Name: AMBIENT SUPER MULTIVAC 50 IFS
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10839781
• MDR Text Key: 216314120
• Report Number: 3006524618-2020-00994
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470006551
• UDI-Public: 00817470006551
• Combination Product (y/n): N
• PMA/PMN Number: K180848
• 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: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2022
• Device Model Number: ASHA4830-01
• Device Catalogue Number: ASHA4830-01
• Device Lot Number: 2042149
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention