MAUDE Adverse Event Report: ARTHREX, INC. APOLLO RF MP50; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	AR-9815
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The arthrex ref ar-9815 apollorf mp50 aspirating ablator 50 multi-port was used in knee arthroscopy and a piece of the insulation came off in the patient's knee.This was removed during case and there was no patient harm.The broken instrument was switched out to a new one.

• Brand Name: APOLLO RF MP50
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside blvd; naples FL 34108
• MDR Report Key: 7689581
• Report Number: 7689581
• Device Sequence Number: 16805253
• Product Code: GEI
• UDI-Device Identifier: 00888867142527
• UDI-Public: (01)00888867142527
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/02/2018
• Report Date (Section F): 07/02/2018

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 Model Number: AR-9815
• Device Catalogue Number: AR-9815
• Device Lot Number: S180030
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/16/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 79
• Date Report Sent to FDA: 07/02/2018