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 07/28/2021

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

H3, h6: the reported device was received for evaluation.A visual inspection of the returned instrument shows no manufacturing abnormalities.The electrode wires are partially detached.The wand cable and connector are free from any physical damage.Product was out of the original packaging.No packaging returned.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 found similar reported events.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 review of the customer provided image shows a used wand with two wires partially detached on electrode.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.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.It was determined the device contributed to the reported event.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) hitting the device tip against a hard surface.(2) using the device as a lever to enlarge surgical site.(3) mechanical displacement of tissue through applied force.No containment or corrective actions are recommended at this time.

• 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: 12340619
• MDR Text Key: 267232339
• Report Number: 3006524618-2021-00850
• 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

• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/19/2021
• Supplement Dates Manufacturer Received: 08/12/2022
• Supplement Dates FDA Received: 08/16/2022
• 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