MAUDE Adverse Event Report: ARTHROCARE CORP. STARVAC 90 ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	ASC4251-01
Medical Device Problem Codes	Overheating of Device (1437); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a shoulder surgery the starvac wand black insulation on the shaft charred and came loose.The device still have blistering on the distal shaft due to overheating.The procedure was successfully completed without a significant delay using a back-up device.No patient injury or complications were reported.
Additional Manufacturer Narrative
The reported device, used 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 device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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 investigation will be reopened for evaluation.

• Brand Name: STARVAC 90 ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 12160481
• Report Number: 3006524618-2021-00760
• Device Sequence Number: 19978854
• Product Code: GEI
• UDI-Device Identifier: 00817470001716
• UDI-Public: 00817470001716
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 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: 01/21/2024
• Device Model Number: ASC4251-01
• Device Catalogue Number: ASC4251-01
• Device Lot Number: 2066036
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1