MAUDE Adverse Event Report: ARTHROCARE CORP. PROCISE MINI LARYNGEAL COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EIC7071-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case- (b)(4).
Event or Problem Description
It was reported that during a vocal cord polyp surgery, the wire of the procise mini wand electrode fell off and it was taken out.The procedure was successfully completed using a back-up device.It is unknown if a delay happened during the procedure.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that during a vocal cord polyp surgery, the wire of the precise mini wand electrode fell off and break inside the patient all the pieces were removed using tweezer.The procedure was successfully completed using a back-up device, without a significant delay.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
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 visual inspection of the returned instrument shows shaft is damaged and electrode has been detached.The device was plugged into the controller and registered settings (7,3).The wand was not able to generate plasms due to detached electrode and damage to the shaft.A review of customer provided image shows a used wand, damaged shaft, and broken piece of electrode in a bag, 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.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.Internal complaint reference: (b)(4).

• Brand Name: PROCISE MINI LARYNGEAL COBLATOR II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 11080366
• Report Number: 3006524618-2020-01123
• Device Sequence Number: 3754358
• Product Code: GEI
• UDI-Device Identifier: 00817470000597
• UDI-Public: 00817470000597
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K070374
• 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
• Report Date (Section B): 04/19/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/18/2021
• Device Model Number: EIC7071-01
• Device Catalogue Number: EIC7071-01
• Device Lot Number: 2020267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Initial Date Received by Manufacturer: 11/26/2020
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 DA