MAUDE Adverse Event Report: ARTHROCARE CORP. 2.3MM SHORT BEVEL 35 DEGREE ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	ASC2530-01
Medical Device Problem Codes	Break (1069); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the rod of the bevel wand has come loose.This was noticed during set up; therefore, no patient was involved.A backup device was available and no delay was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records 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 found related failures; this failure mode will be trended to assess for any necessary corrective actions.A relationship, if any, between the subject device and the reported event could not be determined.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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
The reported device, intended for use 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 no manufacturing abnormalities.The shaft is slightly loose.During functional testing the device was plugged into the controller and registered settings (1,7).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.The complaint was verified.Factors which contribute to the reported event: (1) the wand is designed for ablation and/or coagulation only, and not for mechanical displacement of tissue through applied force (2) do not use the wand as a lever to enlarge a surgical site or gain access to tissue as this may result in a bent or detached electrode, damage to device, and/or a cracked spacer leading to patient injury.No containment or corrective actions are recommended at this time.

• Brand Name: 2.3MM SHORT BEVEL 35 DEGREE ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10767249
• Report Number: 3006524618-2020-00940
• Device Sequence Number: 3645676
• Product Code: GEI
• UDI-Device Identifier: 00817470001914
• UDI-Public: 00817470001914
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K033584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2021

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 Expiration Date: 12/18/2022
• Device Model Number: ASC2530-01
• Device Catalogue Number: ASC2530-01
• Device Lot Number: 2046992
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 11/23/2020; 08/16/2021
• Initial Report FDA Received Date: 10/31/2020
• Supplement Report FDA Received Date: 12/04/2020; 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1