MAUDE Adverse Event Report: ARTHROCARE CORP. MICROBLATOR 30 ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	AC4050-01
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during an anterior cruciate ligament (acl) arthroscopy, the "30° microblator wand" showed an e4 error.The procedure was successfully completed without delay using a back-up device.No patient injuries 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
H3,h6: the device, used in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined since the product was not returned for evaluation.A dhr/batch record review could not be conducted as no serial/lot number was provided.A complaint history review found related failures; this failure mode will be trended to assess for any necessary corrective actions visual inspection and functional testing could not be performed since the device was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.Potential factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: 1) an e-4 (wand short) error will occur if the generator detects a power spike; the power spike could be the result of a wand short or the wand striking a conductive surface with the electrode.2) an issue with one of the concomitant devices in use at the time of this complaint event.No containment or corrective actions are recommended at this time.
Additional Manufacturer Narrative
H11: report was inadvertently submitted under manufacturer number "8010764" but the correct manufacturer number is "3006524618." manufacturing registering site corrected on d3.
Additional Manufacturer Narrative
H10.H3, h6: the device, used 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 extensive electrode erosion with discoloration on the return electrode.There are no manufacturing abnormalities visually observed with the returned wand.A dhr/batch record review could not be conducted as no serial/lot number was provided.A complaint history review found related failures; this failure mode will be trended to assess for any necessary corrective actions.During functional evaluation the wand was plugged into a known good quantum 2 controller and activated with default, min and max settings.After 30 seconds of activation the device creates an error e-4 message with the red attention led.The complaint was verified.The root cause could be determined to be a random component failure without any design or manufacturing issue.An e4 will occur if: 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 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 containment or corrective actions are recommended at this time.

• Brand Name: MICROBLATOR 30 ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10074347
• Report Number: 8010764-2020-00001
• Device Sequence Number: 11478480
• Product Code: GEI
• UDI-Device Identifier: 00817470003123
• UDI-Public: 817470003123
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K0333584
• 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,Followup,Followup
• Report Date (Section B): 07/30/2020

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 Catalogue Number: AC4050-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 05/27/2020; 06/19/2020; 07/27/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 05/29/2020; 06/25/2020; 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1