MAUDE Adverse Event Report: ARTHROCARE CORP. PROCISE MINI LARYNGEAL COBLATOR II; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	EICA7071-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a procedure, a wand was used and after a few minutes the tip stopped working, it did not cut and when it was removed it no longer had the electrode.Backup device was available to complete the procedure.No significant delay and no patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H10 h3, h6: the reported device, used 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 complaint history review concluded this was an isolated repeat issue.A review of the instructions for use found that the device can not be used for mechanical displacement of tissue through applied force, which may result in bent or detached electrodes.A review of risk management files found that the reported failure was documented appropriately.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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10 h3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.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.A visual inspection of the returned instrument shows no manufacturing abnormalities.The electrode is detached.Product was out of the original packaging.No packaging returned.The device was plugged into the controller and registered settings (7,3).The wand was able to generate plasma as intended.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.The complaint was confirmed.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: PROCISE MINI LARYNGEAL COBLATOR II
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 11440251
• Report Number: 3006524618-2021-00284
• Device Sequence Number: 14326931
• Product Code: GAT
• UDI-Device Identifier: 00817470004311
• UDI-Public: 00817470004311
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K202006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EICA7071-01
• Device Catalogue Number: EICA7071-01
• Device Lot Number: 2030259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 04/14/2021; 10/29/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 04/15/2021; 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention