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

Model Number EIC5872-01

Device Problem Crack (1135)

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

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that the wand had an electrode cracked.It is unknown when the event occurred related to surgery.The procedure was completed without significant delay using a back-up device.No patient injury or other complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).H10: h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the device and the reported event.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 a repeat issue.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate a clinical review states per the complaint details, it is unknown when the electrode crack occurred in relation to the surgery.Base on the limited information provided, a thorough medical investigation cannot be rendered, nor can a root cause of the reported crack be determined.Therefore, if any fragments of the cracked electrode are retained inside of the patient, we cannot rule out the possibility of micro-motion and/or migration of the any possible retained fragments cannot be determined.According to the report, the procedure was completed without significant delay using a back-up device.Since no patient injury or other complications were reported, no further clinical/medical assessment is warranted at this time.Should any other medical information be provided, this complaint would be re-assessed.A review of the customer provided image shows a used wand with two wires partially detached on electrode.The complaint was confirmed.Factors that could have contributed to the reported event include: hitting the device tip against a hard surface.Using the device as a lever to enlarge surgical site.Mechanical displacement of tissue through applied force.No containment or corrective actions are recommended at this time.

Event Description

It was reported that the wand had an electrode cracked.It is unknown when the event occurred related to surgery.There was a non significant delay and a back-up device was available.No further complications were reported.

• Brand Name: EVAC 70 XTRA COBLATOR II
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12340624
• MDR Text Key: 267228792
• Report Number: 3006524618-2021-00851
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470003185
• UDI-Public: 00817470003185
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K070374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2023
• Device Model Number: EIC5872-01
• Device Catalogue Number: EIC5872-01
• Device Lot Number: 2056696
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2020
• 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
• Patient Sex: Male