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

Model Number	AC1345-01
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that during a rotator cuff repair the wand showed an e4 error code.The procedure was successfully completed without significant 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: 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.No visual issues were observed.A review of the customer provided image shows e4 error on the console.A functional evaluation revealed the wand was able to generate plasma as intended.An e4 error was not observed during testing.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 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.

• Brand Name: ELIMINATOR ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 11141936
• Report Number: 3006524618-2021-00050
• Device Sequence Number: 2350112
• Product Code: GEI
• UDI-Device Identifier: 00817470001860
• UDI-Public: 00817470001860
• 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): 02/26/2021

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 Model Number: AC1345-01
• Device Catalogue Number: AC1345-01
• Device Lot Number: 2059244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1