MAUDE Adverse Event Report: CONMED UTICA AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	AES-50SP
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional 510k number k153499 manufacturer narrative: the reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the aes-50sp paradigm edge hip probe, 50 degree was being used on (b)(6) 2023 during a hip arthroscopy procedure and ¿circular metal face of the probe fell off from the handpiece and into the joint.It took 2 hours to try and get it out of the joint.Caused a major delay in surgery but no patient harm.Patient injury? no, bigger incision though.¿.The procedure was completed.After further assessment it was found that the fragment was retrieved.There was no extended stay at the hospital for the patient.This report is being raised due to the reported injury of a larger incision was needed to retrieve the fragments from the patient.
Event or Problem Description
The sales representative reported on behalf of the customer that the aes-50sp paradigm edge hip probe, 50 degree was being used on (b)(6) 23 during a hip arthroscopy procedure and ¿circular metal face of the probe fell off from the handpiece and into the joint.It took 2 hours to try and get it out of the joint.Caused a major delay in surgery but no patient harm.Patient injury? no, bigger incision though.¿.The procedure was completed.After further assessment it was found that the fragment was retrieved.There was no extended stay at the hospital for the patient.This report is being raised due to the reported injury of a larger incision was needed to retrieve the fragments from the patient.
Additional Manufacturer Narrative
Evaluation found the active electrode completely detached from the ceramic insulator during use in a hip procedure.The electrode and remaining probe assembly handle were returned.The epoxy adhesive bond appears to have degraded to the point of failure due to the heating of the electrode tang located inside the ceramic component while using the device.The active wire connection to the electrode tang exhibits softening of the solder joint and detachment of the electrode from the wire.It is suspected that complete detachment of the active electrode may have occurred when the distal tip is slightly buried intermittently closing off the aspiration suction line causing sudden increased heating that is degrading the bond line and solder connection of the wire and electrode.There is no evidence of misuse by the user surgeon.There is no evidence of manufacturing defects as the probe assembly appears to be assembled correctly.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.A 2 year lot history review shows a total of 2 devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 64 reports, regarding 66 devices, for this device family and failure mode.During this same time frame 209,719 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.0003.Per the instructions for use, the user is advised the following: maintain the probe tip, including the return electrode, in the field of view at all times.A determination for further investigation has been initiated.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: robin drum ; 11311 concept blvd.; largo, FL 33773 ; 8653881978
• MDR Report Key: 16952700
• Report Number: 1320894-2023-00089
• Device Sequence Number: 19736357
• Product Code: GEI
• UDI-Device Identifier: 20653405988332
• UDI-Public: (01)20653405988332(17)280222(10)202302231
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K140578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: AES-50SP
• Device Catalogue Number: AES-50SP
• Device Lot Number: 202302231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic