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

Catalog Number	AC5531-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee arthroscopy procedure, the surgeon was cleaning the patient cartilage and after several minutes the electrode tip completely detached from the device and fell into the patient wound.X-rays were performed to locate the electrode, but despite the attempts for retrieval, it could not be removed from the patient.This caused a delay in the procedure of more than two hours and the initial knee repair was not completed.
Additional Manufacturer Narrative
The product, used for treatment, was returned for evaluation.There was a relationship found between the complaint and the returned device.Visual inspection under magnification shows the spacer has been detached and the ring electrode is damaged and bent.There are a significant amount of scratch marks present on the exposed shaft near the tip.The shaft has been slightly bent near the handle of the device.There are no manufacturing abnormalities visually observed with the remaining components of the wand.Due to the damage the tip sustained a functional evaluation could not be conducted.The complaint has been visually verified and the root cause could not be determined with confidence.It is possible that the device either came into contact with a hard (metallic) object or was continuously rubbed against another object which will cause this type of failure.Also, this device is not designed for mechanical displacement of tissue through applied force.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• 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: 8754309
• Report Number: 3006524618-2019-00312
• Device Sequence Number: 16566704
• Product Code: GEI
• UDI-Device Identifier: 00817470003512
• UDI-Public: 00817470003512
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K033584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2021
• Device Catalogue Number: AC5531-01
• Device Lot Number: 2017121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1