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

Catalog Number ASCA5001-01

Device Problems Self-Activation or Keying (1557); Electrical Shorting (2926)

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

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference number: (b)(4).H3, h6: the reported device was received for evaluation.Visual inspection observed the returned instrument showed no manufacturing abnormalities.The electrodes have been used.Bio debris is present.The device was sent out of the original packaging.No packaging returned.A functional evaluation showed that the device generated an e7 error when the wand was connected.When the bypass box was plugged in for use, the activate sound started and a light for the "coag" lit up, without being activated with the foot pedal, indicating a short.The resistance measured at 1.40 kilo ohms.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause has been associated with an electrical component failure.Factors that could have contributed to the failure include moisture in the connection causing a wand short, incomplete connection or wire damaged inside the wand cable.No containment or corrective actions are recommended at this time.

Event Description

It was reported that, when the ambient megavac 90 was plugged to the bypass box for use, the activate sound started and a light for the "coag" lit up, without being activated with the foot pedal, indicating a short.The deficiency was observed while performing the investigation for the device; therefore, there was no patient involvement.

• Brand Name: AMBIENT MEGAVAC 90
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18741898
• MDR Text Key: 335981274
• Report Number: 3006524618-2024-00074
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K083306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASCA5001-01
• Device Lot Number: 2123340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1