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

Model Number	AC4050-01
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during wrist arthroscopy the microblator worked intermittently.The wand was plugged in properly and foot pedal was working fine.There was a delay of under 30 min and the procedure was completed with a change in surgical technique, the surgeon proceeded to do an open surgery.No further 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 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 the device history records 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 relationship, if any, between the subject device and the reported event could not be determined.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found use only conductive media (e.G.Saline,ringer¿s lactate, etc.).Do not use non-conductive media (e.G.Sterile water, air, gas, glycine, etc.);no containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.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: 10491743
• Report Number: 3006524618-2020-00717
• Device Sequence Number: 3119689
• Product Code: GEI
• UDI-Device Identifier: 00817470003123
• UDI-Public: 00817470003123
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 09/28/2020

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 Expiration Date: 10/01/2022
• Device Model Number: AC4050-01
• Device Catalogue Number: AC4050-01
• Device Lot Number: 2043183
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention