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

Model Number	AC2430-01
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an acl, the bevel 45 icw front section was burned, and it could not be used.The device over-heated, and became hot to touch.The procedure was successfully completed without a 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: h2, h3, h6.The reported device, used in treatment, was returned for evaluation.There was no relationship found between the reported incident and the returned device.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 an isolate issue.The customer has provided a picture of the device label and shaft.Visual inspection under magnification of the wand shows dried blood/tissue and minimal electrode erosion.The device was plugged into the controller and activated in saline solution at the default and max settings and performed as intended.The complaint was not confirmed.Factors that could have contributed to the reported event include: (1) overheating due to a long activation of the wand; (2) low flow and circulation of saline solution to prevent heating.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• 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: 10912850
• Report Number: 3006524618-2020-01036
• Device Sequence Number: 14139294
• 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): 12/26/2020

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: 04/17/2021
• Device Model Number: AC2430-01
• Device Catalogue Number: AC2430-01
• Device Lot Number: 2013196
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 12/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1