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

Model Number ASCA5001-01

Device Problem Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

Case- (b)(4).

Event Description

It was reported that during the set up before the surgery there was an error code e6 when the wand was connected and system generated an alarm noise.No patient injuries or delay reported.Smith and nephew back-up device was available to complete the surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: d9: updated, device received h3,h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection of the returned instrument shows no manufacturing abnormalities.No visual issues were observed.A functional evaluation revealed the controller generated an e7 error when the wand was connected.When used with a bypass box the device generated e6 error code.Inspection of the open wand shows there are no broken wires.There is continuity.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was an isolated event.The complaint was confirmed.Factors that could have contributed to the reported event include: 1) the wand may have experienced a short.2) the t/c wire is damaged between the transition of the handle and the shaft.No containment or corrective actions are recommended at this time.

Manufacturer Narrative

The reported device, intended for use 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 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.No containment or corrective actions are recommended at this time.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: AMBIENT MEGAVAC 90
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 11083966
• MDR Text Key: 224342687
• Report Number: 3006524618-2020-01154
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470001761
• UDI-Public: 00817470001761
• 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,Followup
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Model Number: ASCA5001-01
• Device Catalogue Number: ASCA5001-01
• Device Lot Number: 2053103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1