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

Model Number	AC4050-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an arthroscopy surgery the electrode tip of the microblator wand broke off.All the pieces were removed.A back up device was available.The procedure was completed without delay.No 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
The device, used in treatment, was returned for evaluation.There was a relationship found between the returned device and the reported incident.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 isolated event.A review of the instructions for use found do not contact metal objects while activating the wand.Damage to the tip may result.A review of risk management files found that the reported failure was documented appropriately.Visual inspection of the device showed a complete detachment of the electrode tip.The device was connected to a known good controller, which revealed that while the device's tip was detached, the wand was able to electrically activate with no issues.The complaint was verified as the device's tip was detached.Factors, which may have contributed to the reported complaint include: hitting the device tip against a hard surface such as an insertion cannula.Using the device as a lever to enlarge surgical site.Mechanical displacement of tissue through applied force.Activating the device above recommended settings for prolonged periods of time.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• 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: 10491771
• Report Number: 3006524618-2020-00718
• Device Sequence Number: 16924048
• Product Code: GEI
• UDI-Device Identifier: 00817470003123
• UDI-Public: 00817470003123
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K033584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AC4050-01
• Device Catalogue Number: AC4050-01
• Device Lot Number: 2015309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1