MAUDE Adverse Event Report: ARTHREX, INC. APOLLORF¿ XL90, ASPIRATING ABLATOR 90°; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number APOLLORF¿ XL90, ASPIRATING ABLATOR 90°

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2023

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported on (b)(6) 2023 by a sales representative via sems that an ar-9821 apollo probe fell apart during a case.Case involvement, device breaks during use.

Manufacturer Narrative

Complaint confirmed.One unpackaged ar-9821 apollorf¿ xl90, aspirating ablator, 90° batch number 67168768, was received for investigation.Functional testing was not performed due to the device's connector cable was cut.Visual evaluation found that the aspirating probe electrode face was detached.

• Brand Name: APOLLORF¿ XL90, ASPIRATING ABLATOR 90°
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 16427753
• MDR Text Key: 310138645
• Report Number: 1220246-2023-06343
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00888867267220
• UDI-Public: 00888867267220
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/05/2023

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
• Device Operator: Health Professional
• Device Model Number: APOLLORF¿ XL90, ASPIRATING ABLATOR 90°
• Device Catalogue Number: AR-9821
• Device Lot Number: 67168768
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/02/2023
• Initial Date FDA Received: 02/23/2023
• Supplement Dates Manufacturer Received: 02/02/2023
• Supplement Dates FDA Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1