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

Catalog Number	ASC4251-01
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the starvac showed an error e4 when connected.Incident occurred before the procedure; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, intended for use in treatment, was returned for evaluation.There was a relationship found between the device and the reported incident.Visual inspection under magnification of the wand shows minimal electrode erosion with contamination/ discoloration and scratch/scuff marks on the spacer and cap; there are no manufacturing abnormalities visually observed with the returned wand.During functional evaluation the wand was plugged into a known good quantum 2 controller and activated with default, min and max settings.Immediately after activation the device creates an error e-4 message with the red attention led.The complaint was verified.A complaint history review found no related failures; this failure mode will be trended to assess for any necessary corrective actions a review of manufacturing records for this l/n 2045216 found no deviations or non-conformances during the manufacturing process.The root cause could be determined to be a random component failure without any design or manufacturing issue.An e4 will occur if: (1) the generator detects a power spike.The output is deactivated in order to protect the wand and generator from excessive power delivery.The power spike could be the result of a (2) wand short or the wand striking a conductive surface with the electrode.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.No remedial, corrective or preventive actions were found to be required, as no manufacturing, material or design issues were identified.

• 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: 10124563
• Report Number: 3006524618-2020-00337
• Device Sequence Number: 3513957
• Product Code: GEI
• UDI-Device Identifier: 00817470001716
• UDI-Public: 817470001716
• 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): 08/12/2020

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: 11/01/2022
• Device Catalogue Number: ASC4251-01
• Device Lot Number: 2045216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR