MAUDE Adverse Event Report: ARTHROCARE CORPORATION EVAC 70 XTRA HP COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number EIC5874-01

Device Problem Arcing (2583)

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

Event Date 03/11/2023

Event Type  malfunction  

Event Description

It was reported that during a procedure for tonsillar hypertrophy with adenoid hypertrophy, the evac 70 extra coblator ii wand emitted sparks.Surgery was completed without delay, using a back-up device instead.The incident did not cause any harm to the patient or user.No further complications were reported.No similar events were found on the follow-up operation.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H10: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.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.A review of the device history records show there are 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 similar reported events.A visual inspection of the returned instrument shows no manufacturing abnormalities.The electrode is still attached.Heavy arc/burn damage is seen on the side of the tip and up to the electrode of the device.Product was out of the original packaging.No packaging returned.The opened device was tested and plugged into the controller and registered settings (7,3).When tested the wand was able to generate plasma and coagulation as intended.No sparks or electricity was generated in testing.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include: 1) contact with metal objects while activating the wand.No containment or corrective actions are recommended at this time.

• Brand Name: EVAC 70 XTRA HP COBLATOR II
• 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: 16714569
• MDR Text Key: 313164503
• Report Number: 3006524618-2023-00118
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470004595
• UDI-Public: 00817470004595
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K202006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2023

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 Model Number: EIC5874-01
• Device Catalogue Number: EIC5874-01
• Device Lot Number: 2094612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/11/2023
• Supplement Dates Manufacturer Received: 04/24/2023
• Supplement Dates FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2022
• 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