MAUDE Adverse Event Report: ARTHROCARE CORP. BEVEL 45 ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	AC2430-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case(b)(4).
Event or Problem Description
It was reported that during shoulder cleaning the electrode of the bevel 45 icw wand fell off.There was a s+n back-up device available.No significant delay was reported, and no patient injury or other complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H10 h3, h6: the reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection of the returned instrument shows no manufacturing abnormalities.The electrode has extensive erosion it is not detached.Product was out of the original packaging.No packaging returned.During functional testing the device was plugged into the controller and registered settings (1,6).The wand was able to generate plasma as intended.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.A review of customer provided image shows the packaging of the wand confirming part number ac2430-01 and lot number 2049193.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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.

• Brand Name: BEVEL 45 ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 12316844
• Report Number: 3006524618-2021-00828
• Device Sequence Number: 17186698
• Product Code: GEI
• UDI-Device Identifier: 00817470004540
• UDI-Public: 00817470004540
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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: 02/13/2023
• Device Model Number: AC2430-01
• Device Catalogue Number: AC2430-01
• Device Lot Number: 2049193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 10/20/2021
• 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