MAUDE Adverse Event Report: ARTHROCARE CORP. PARAGON T2 ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	AC5531-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
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 chondroplasty, using the paragon t2 icw the electrode came loose.The electrode was removed with a grasper.The procedure was successfully completed without delay using a back-up device.No patient injury or 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
H10, h2: additional information on e1: facility's address.
Additional Manufacturer Narrative
H10: the device, used in treatment, was not returned for evaluation.There was a relationship found between the device and the reported incident, as an image of the device was submitted by the customer.A review of the device history records for the device 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 a repeat event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found that this device is not designed for mechanical displacement of tissue through applied force.One intra operative photo was provided and it shows a piece of metal coming out of the tissue.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.Visual inspection and functional testing could not be performed since the device was not returned for evaluation; however, the complaint was confirmed as the submitted image provide sufficient evidence to confirm.Potential factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: the tip of the device coming into abrupt contact with a hard (metallic) object, improper insertion or removal from an apparatus, use at a higher than recommended set point or excessive force applied to the tip, vigorous use against bony surfaces, or mechanical displacement of tissue through applied force.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: PARAGON T2 ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 11465380
• Report Number: 3006524618-2021-00299
• Device Sequence Number: 19820116
• Product Code: GEI
• UDI-Device Identifier: 00817470003512
• UDI-Public: 00817470003512
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K033584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2021

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 Expiration Date: 06/03/2022
• Device Model Number: AC5531-01
• Device Catalogue Number: AC5531-01
• Device Lot Number: 2035176
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 03/17/2021; 04/12/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 03/18/2021; 04/13/2021
• 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: Other; Required Intervention
• Patient Age: 45 YR